<table style="width:100%;">
<colgroup>
<col style="width: 10%" />
<col style="width: 14%" />
<col style="width: 9%" />
<col style="width: 4%" />
<col style="width: 2%" />
<col style="width: 4%" />
<col style="width: 2%" />
<col style="width: 17%" />
<col style="width: 0%" />
<col style="width: 1%" />
<col style="width: 3%" />
<col style="width: 24%" />
<col style="width: 2%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="8" rowspan="4"><h1
id="department-of-health-and-human-services">DEPARTMENT OF HEALTH AND
HUMAN SERVICES</h1>
<p>FOOD AND DRUG ADMINISTRATION</p>
<p><strong>APPLICATION TO MARKET A NEW DRUG, BIOLOGIC,</strong></p>
<p><strong>OR AN ANTIBIOTIC DRUG FOR HUMAN USE</strong></p>
<p><em>(Title 21, Code of Federal Regulations, Parts 314 &amp;
601)</em></p></td>
<td colspan="5"><p><em>Form Approved: OMB No. 0910-0430</em></p>
<p id="expiration-date-april-30-2009" class="heading">Expiration Date:
April 30, 2009</p>
<p><em>See OMB Statement on page 2.</em></p></td>
</tr>
<tr class="even">
<td colspan="5"><h4 id="for-fda-use-only">FOR FDA USE ONLY</h4></td>
</tr>
<tr class="odd">
<td colspan="5">APPLICATION NUMBER</td>
</tr>
<tr class="even">
<td colspan="5"></td>
</tr>
<tr class="odd">
<td colspan="13"><strong>APPLICANT INFORMATION</strong></td>
</tr>
<tr class="even">
<td colspan="7">NAME OF APPLICANT</td>
<td colspan="6">DATE OF SUBMISSION</td>
</tr>
<tr class="odd">
<td colspan="7">     </td>
<td colspan="6">     </td>
</tr>
<tr class="even">
<td colspan="7">TELEPHONE NO. <em>(Include Area Code)</em></td>
<td colspan="6">FACSIMILE <em>(FAX)</em> Number <em>(Include Area
Code)</em></td>
</tr>
<tr class="odd">
<td colspan="7">     </td>
<td colspan="6">     </td>
</tr>
<tr class="even">
<td colspan="7">APPLICANT ADDRESS <em>(Number, Street, City, State,
Country, ZIP Code or Mail Code, and U.S. License number if previously
issued):</em></td>
<td colspan="6"><p>AUTHORIZED U.S. AGENT NAME &amp; ADDRESS <em>(Number,
Street, City, State,</em></p>
<p><em>ZIP Code, telephone &amp; FAX number)</em> IF APPLICABLE</p></td>
</tr>
<tr class="odd">
<td colspan="7">     </td>
<td colspan="6">     </td>
</tr>
<tr class="even">
<td colspan="13"><strong>PRODUCT DESCRIPTION</strong></td>
</tr>
<tr class="odd">
<td colspan="13">NEW DRUG OR ANTIBIOTIC APPLICATION NUMBER, OR BIOLOGICS
LICENSE APPLICATION NUMBER <em>(If previously issued)</em>      </td>
</tr>
<tr class="even">
<td colspan="7">ESTABLISHED NAME <em>(e.g., Proper name, USP/USAN
name)</em></td>
<td colspan="6">PROPRIETARY NAME <em>(trade name)</em> IF ANY</td>
</tr>
<tr class="odd">
<td colspan="7">     </td>
<td colspan="6">     </td>
</tr>
<tr class="even">
<td colspan="10">CHEMICAL/BIOCHEMICAL/BLOOD PRODUCT NAME <em>(If
any)</em></td>
<td colspan="3">CODE NAME <em>(If any)</em></td>
</tr>
<tr class="odd">
<td colspan="10">     </td>
<td colspan="3">     </td>
</tr>
<tr class="even">
<td colspan="3">DOSAGE FORM:</td>
<td colspan="7">STRENGTHS:</td>
<td colspan="3">ROUTE OF ADMINISTRATION:</td>
</tr>
<tr class="odd">
<td colspan="3">     </td>
<td colspan="7">     </td>
<td colspan="3">     </td>
</tr>
<tr class="even">
<td colspan="13">(PROPOSED) INDICATION(S) FOR USE:</td>
</tr>
<tr class="odd">
<td colspan="13">     </td>
</tr>
<tr class="even">
<td colspan="13"><strong>APPLICATION DESCRIPTION</strong></td>
</tr>
<tr class="odd">
<td colspan="13"><p>APPLICATION TYPE</p>
<p><em>(check one)</em> NEW DRUG APPLICATION (CDA, 21 CFR 314.50)
ABBREVIATED NEW DRUG APPLICATION (ANDA, 21 CFR 314.94)</p>
<p> BIOLOGICS LICENSE APPLICATION (BLA, 21 CFR Part 601)</p></td>
</tr>
<tr class="even">
<td colspan="13">IF AN NDA, IDENTIFY THE APPROPRIATE TYPE 505 (b)(1) 505
(b)(2)</td>
</tr>
<tr class="odd">
<td colspan="13">IF AN ANDA, OR 505(b)(2), IDENTIFY THE REFERENCE LISTED
DRUG PRODUCT THAT IS THE BASIS FOR THE SUBMISSION</td>
</tr>
<tr class="even">
<td>Name of Drug</td>
<td colspan="5">     </td>
<td colspan="3">Holder of Approved Application</td>
<td colspan="3">     </td>
<td></td>
</tr>
<tr class="odd">
<td colspan="13"></td>
</tr>
<tr class="even">
<td colspan="13"><p>TYPE OF SUBMISSION <em>(check one)</em> ORIGINAL
APPLICATION AMENDMENT TO APENDING APPLICATION RESUBMISSION</p>
<p> PRESUBMISSION ANNUAL REPORT ESTABLISHMENT DESCRIPTION SUPPLEMENT
EFFICACY SUPPLEMENT</p>
<p> LABELING SUPPLEMENT CHEMISTRY MANUFACTURING AND CONTROLS SUPPLEMENT
OTHER</p></td>
</tr>
<tr class="odd">
<td colspan="11">IF A SUBMISSION OF PARTIAL APPLICATION, PROVIDE LETTER
DATE OF AGREEMENT TO PARTIAL SUBMISSION:</td>
<td>     </td>
<td></td>
</tr>
<tr class="even">
<td colspan="11"></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="13">IF A SUPPLEMENT, IDENTIFY THE APPROPRIATE CATEGORY CBE
CBE-30 Prior Approval (PA)</td>
</tr>
<tr class="even">
<td colspan="13">REASON FOR SUBMISSION</td>
</tr>
<tr class="odd">
<td colspan="13">     </td>
</tr>
<tr class="even">
<td colspan="13">PROPOSED MARKETING STATUS <em>(check one)</em>
PRESCRIPTION PRODUCT (Rx) OVER THE COUNTER PRODUCT (OTC)</td>
</tr>
<tr class="odd">
<td colspan="2">NUMBER OF VOLUMES SUBMITTED</td>
<td colspan="2">     </td>
<td></td>
<td colspan="8">THIS APPLICATION IS PAPER PAPER AND ELECTRONIC
ELECTRONIC</td>
</tr>
<tr class="even">
<td colspan="13"></td>
</tr>
<tr class="odd">
<td colspan="13"><p><strong>ESTABLISHMENT INFORMATION (Full
establishment information should be provided in the body of the
Application.)</strong></p>
<p>Provide locations of all manufacturing, packaging and control sites
for drug substance and drug product (continuation sheets may be used if
necessary). Include name,</p>
<p>address, contact, telephone number, registration number (CFN), DMF
number, and manufacturing steps and/or type of testing (e.g. Final
dosage form, Stability testing)</p>
<p>conducted at the site. Please indicate whether the site is ready for
inspection or, if not, when it will be ready.</p></td>
</tr>
<tr class="even">
<td colspan="13">     </td>
</tr>
<tr class="odd">
<td colspan="13"><strong>Cross References (list related License
Applications, INDs, NDAs, PMAs, 510(k)s, IDEs, BMFs, and DMFs referenced
in the current application)</strong></td>
</tr>
<tr class="even">
<td colspan="13">     </td>
</tr>
</tbody>
</table>

+---+---------------+------+-------------------+---------+-----------+
| > |               |      |                   |         |           |
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|   |               |      |                   |         |           |
| * |               |      |                   |         |           |
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|   |               |      |                   |         |           |
| a |               |      |                   |         |           |
| l |               |      |                   |         |           |
| l |               |      |                   |         |           |
| > |               |      |                   |         |           |
|   |               |      |                   |         |           |
| t |               |      |                   |         |           |
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| ) |               |      |                   |         |           |
| * |               |      |                   |         |           |
+---+---------------+------+-------------------+---------+-----------+
|   | 1\. Index     |      |                   |         |           |
+---+---------------+------+-------------------+---------+-----------+
|   | 2\. Labeling  |      |                   |         |           |
|   | *(check one)* |      |                   |         |           |
|   | Draft         |      |                   |         |           |
|   | Labeling      |      |                   |         |           |
|   | Final Printed |      |                   |         |           |
|   | Labeling      |      |                   |         |           |
+---+---------------+------+-------------------+---------+-----------+
|   | 3\. Summary   |      |                   |         |           |
|   | (21 CFR       |      |                   |         |           |
|   | 314.50 (c))   |      |                   |         |           |
+---+---------------+------+-------------------+---------+-----------+
|   | 4\. Chemistry |      |                   |         |           |
|   | section       |      |                   |         |           |
+---+---------------+------+-------------------+---------+-----------+
|   | A. Chemistry, |      |                   |         |           |
|   | m             |      |                   |         |           |
|   | anufacturing, |      |                   |         |           |
|   | and controls  |      |                   |         |           |
|   | information   |      |                   |         |           |
|   | (e.g., 21 CFR |      |                   |         |           |
|   | 314.50(d)(1); |      |                   |         |           |
|   | 21 CFR 601.2) |      |                   |         |           |
+---+---------------+------+-------------------+---------+-----------+
|   | B. Samples    |      |                   |         |           |
|   | (21 CFR       |      |                   |         |           |
|   | 314.50        |      |                   |         |           |
|   | (e)(1); 21    |      |                   |         |           |
|   | CFR 601.2     |      |                   |         |           |
|   | (a)) (Submit  |      |                   |         |           |
|   | only upon     |      |                   |         |           |
|   | FDA's         |      |                   |         |           |
|   | request)      |      |                   |         |           |
+---+---------------+------+-------------------+---------+-----------+
|   | C. Methods    |      |                   |         |           |
|   | validation    |      |                   |         |           |
|   | package       |      |                   |         |           |
|   | (e.g., 21 CFR |      |                   |         |           |
|   | 314           |      |                   |         |           |
|   | .50(e)(2)(i); |      |                   |         |           |
|   | 21 CFR 601.2) |      |                   |         |           |
+---+---------------+------+-------------------+---------+-----------+
|   | 5\.           |      |                   |         |           |
|   | Nonclinical   |      |                   |         |           |
|   | pharmacology  |      |                   |         |           |
|   | and           |      |                   |         |           |
|   | toxicology    |      |                   |         |           |
|   | section       |      |                   |         |           |
|   | (e.g., 21 CFR |      |                   |         |           |
|   | 314.50(d)(2); |      |                   |         |           |
|   | 21 CFR 601.2) |      |                   |         |           |
+---+---------------+------+-------------------+---------+-----------+
|   | 6\. Human     |      |                   |         |           |
|   | pha           |      |                   |         |           |
|   | rmacokinetics |      |                   |         |           |
|   | and           |      |                   |         |           |
|   | bi            |      |                   |         |           |
|   | oavailability |      |                   |         |           |
|   | section       |      |                   |         |           |
|   | (e.g., 21 CFR |      |                   |         |           |
|   | 314.50(d)(3); |      |                   |         |           |
|   | 21 CFR 601.2) |      |                   |         |           |
+---+---------------+------+-------------------+---------+-----------+
|   | 7\. Clinical  |      |                   |         |           |
|   | Microbiology  |      |                   |         |           |
|   | (e.g., 21 CFR |      |                   |         |           |
|   | 314.50(d)(4)) |      |                   |         |           |
+---+---------------+------+-------------------+---------+-----------+
|   | 8\. Clinical  |      |                   |         |           |
|   | data section  |      |                   |         |           |
|   | (e.g., 21 CFR |      |                   |         |           |
|   | 314.50(d)(5); |      |                   |         |           |
|   | 21 CFR 601.2) |      |                   |         |           |
+---+---------------+------+-------------------+---------+-----------+
|   | 9\. Safety    |      |                   |         |           |
|   | update report |      |                   |         |           |
|   | (e.g., 21 CFR |      |                   |         |           |
|   | 314.50(       |      |                   |         |           |
|   | d)(5)(vi)(b); |      |                   |         |           |
|   | 21 CFR 601.2) |      |                   |         |           |
+---+---------------+------+-------------------+---------+-----------+
|   | 10\.          |      |                   |         |           |
|   | Statistical   |      |                   |         |           |
|   | section       |      |                   |         |           |
|   | (e.g., 21 CFR |      |                   |         |           |
|   | 314.50(d)(6); |      |                   |         |           |
|   | 21 CFR 601.2) |      |                   |         |           |
+---+---------------+------+-------------------+---------+-----------+
|   | 11\. Case     |      |                   |         |           |
|   | report        |      |                   |         |           |
|   | tabulations   |      |                   |         |           |
|   | (e.g., 21 CFR |      |                   |         |           |
|   | 314.50(f)(1); |      |                   |         |           |
|   | 21 CFR 601.2) |      |                   |         |           |
+---+---------------+------+-------------------+---------+-----------+
|   | 12\. Case     |      |                   |         |           |
|   | report forms  |      |                   |         |           |
|   | (e.g., 21 CFR |      |                   |         |           |
|   | 314.50        |      |                   |         |           |
|   | (f)(2); 21    |      |                   |         |           |
|   | CFR 601.2)    |      |                   |         |           |
+---+---------------+------+-------------------+---------+-----------+
|   | 13\. Patent   |      |                   |         |           |
|   | information   |      |                   |         |           |
|   | on any patent |      |                   |         |           |
|   | which claims  |      |                   |         |           |
|   | the drug (21  |      |                   |         |           |
|   | U.S.C. 355(b) |      |                   |         |           |
|   | or (c))       |      |                   |         |           |
+---+---------------+------+-------------------+---------+-----------+
|   | 14\. A patent |      |                   |         |           |
|   | certification |      |                   |         |           |
|   | with respect  |      |                   |         |           |
|   | to any patent |      |                   |         |           |
|   | which claims  |      |                   |         |           |
|   | the drug (21  |      |                   |         |           |
|   | U.S.C. 355    |      |                   |         |           |
|   | (b)(2) or     |      |                   |         |           |
|   | (j)(2)(A))    |      |                   |         |           |
+---+---------------+------+-------------------+---------+-----------+
|   | 15\.          |      |                   |         |           |
|   | Establishment |      |                   |         |           |
|   | description   |      |                   |         |           |
|   | (21 CFR Part  |      |                   |         |           |
|   | 600, if       |      |                   |         |           |
|   | applicable)   |      |                   |         |           |
+---+---------------+------+-------------------+---------+-----------+
|   | 16\.          |      |                   |         |           |
|   | Debarment     |      |                   |         |           |
|   | certification |      |                   |         |           |
|   | (FD&C Act 306 |      |                   |         |           |
|   | (k)(1))       |      |                   |         |           |
+---+---------------+------+-------------------+---------+-----------+
|   | 17\. Field    |      |                   |         |           |
|   | copy          |      |                   |         |           |
|   | certification |      |                   |         |           |
|   | (21 CFR       |      |                   |         |           |
|   | 314.50        |      |                   |         |           |
|   | (l)(3))       |      |                   |         |           |
+---+---------------+------+-------------------+---------+-----------+
|   | 18\. User Fee |      |                   |         |           |
|   | Cover Sheet   |      |                   |         |           |
|   | (Form FDA     |      |                   |         |           |
|   | 3397)         |      |                   |         |           |
+---+---------------+------+-------------------+---------+-----------+
|   | 19\.          |      |                   |         |           |
|   | Financial     |      |                   |         |           |
|   | Information   |      |                   |         |           |
|   | (21 CFR Part  |      |                   |         |           |
|   | 54)           |      |                   |         |           |
+---+---------------+------+-------------------+---------+-----------+
|   | 20\. OTHER    |      |                   |         |           |
|   | *(Specify)*   |      |                   |         |           |
|   |               |      |                   |         |           |
+---+---------------+------+-------------------+---------+-----------+
| # |               |      |                   |         |           |
| # |               |      |                   |         |           |
| # |               |      |                   |         |           |
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| E |               |      |                   |         |           |
| R |               |      |                   |         |           |
| T |               |      |                   |         |           |
| I |               |      |                   |         |           |
| F |               |      |                   |         |           |
| I |               |      |                   |         |           |
| C |               |      |                   |         |           |
| A |               |      |                   |         |           |
| T |               |      |                   |         |           |
| I |               |      |                   |         |           |
| O |               |      |                   |         |           |
| N |               |      |                   |         |           |
|   |               |      |                   |         |           |
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+---+---------------+------+-------------------+---------+-----------+
| S |               |      | TYPED NAME AND    |         | DATE:     |
| I |               |      | TITLE             |         |           |
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+---+---------------+------+-------------------+---------+-----------+
|   |               |      |                   |         |           |
+---+---------------+------+-------------------+---------+-----------+
| A |               |      |                   | Te      |           |
| D |               |      |                   | lephone |           |
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|   |               |      |                   | (     ) |           |
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+---+---------------+------+-------------------+---------+-----------+
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| : |               |      |                   |         |           |
+---+---------------+------+-------------------+---------+-----------+
| D |               | De   |                   | An      |           |
| e |               | part |                   | agency  |           |
| p |               | ment |                   | may not |           |
| a |               | of   |                   | conduct |           |
| r |               | He   |                   | or      |           |
| t |               | alth |                   | s       |           |
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| r |               | tion |                   | OMB     |           |
| v |               | and  |                   | control |           |
| i |               | Rese |                   | number. |           |
| c |               | arch |                   |         |           |
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| n |               |      |                   |         |           |
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| D |               | ckvi |                   |         |           |
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| g |               | 20   |                   |         |           |
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| d |               | 1448 |                   |         |           |
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+---+---------------+------+-------------------+---------+-----------+

+-----------------------------------------------------------------------+
| ##### INSTRUCTIONS FOR FILLING OUT FORM FDA 356h                      |
|                                                                       |
| > **APPLICANT INFORMATION** This section should include the name,     |
| > street address, telephone                                           |
| >                                                                     |
| > and facsimile numbers of the legal person or entity submitting the  |
| > application in the appropriate areas.                               |
| >                                                                     |
| > Note that, in the case of biological products, this is the name of  |
| > the legal entity or person to whom the                              |
| >                                                                     |
| > license will be issued. The name, street address and telephone      |
| > number of the legal person or entity                                |
| >                                                                     |
| > authorized to represent a non-U.S. applicant should be entered in   |
| > the indicated area. Only one person                                 |
| >                                                                     |
| > should sign the form.                                               |
| >                                                                     |
| > **PRODUCT DESCRIPTION** This section should include all of the      |
| > information necessary to identify                                   |
| >                                                                     |
| > the product that is the subject of this submission. For new         |
| > applications, the proposed indication                               |
| >                                                                     |
| > should be given. For supplements to an approved application, please |
| > give the approved indications for                                   |
| >                                                                     |
| > use.                                                                |
| >                                                                     |
| > **APPLICATION INFORMATION** If this submission is an ANDA or        |
| > 505(b)(2), this section should                                      |
| >                                                                     |
| > include the name of the approved drug that is the basis of the      |
| > application and identify the holder of                              |
| >                                                                     |
| > the approved application in the indicated areas.                    |
| >                                                                     |
| > **TYPE OF SUBMISSION** should be indicated by checking the          |
| > appropriate box:                                                    |
| >                                                                     |
| > **Original Application** = a complete new application that has      |
| > never before been submitted;                                        |
| >                                                                     |
| > **Amendment to a Pending Application =** all submissions to pending |
| > original applications, or                                           |
| >                                                                     |
| > pending supplements to approved applications, including responses   |
| > to Information Request Letters;                                     |
| >                                                                     |
| > **Resubmission** = a complete response to an action letter, or      |
| > submission of an application that has been                          |
| >                                                                     |
| > the subject of a withdrawal or a refusal to file action;            |
| >                                                                     |
| > **Presubmission** = information submitted prior to the submission   |
| > of a complete new application;                                      |
| >                                                                     |
| > **Annual Report** = periodic reports for licensed biological        |
| > products (for NDAs Form FDA-2252                                    |
| >                                                                     |
| > should be used as required in 21 CFR 314.81 (b)(2));                |
| >                                                                     |
| > **Establishment Description Supplement** = supplements to the       |
| > information contained in the                                        |
| >                                                                     |
| > Establishment Description section (#15) for biological products;    |
| >                                                                     |
| > **Efficacy Supplement** = submissions for such changes as a new     |
| > indication or dosage regimen for an                                 |
| >                                                                     |
| > approved product, a comparative efficacy claim naming another       |
| > product, or a significant alteration in                             |
| >                                                                     |
| > the patient population; e.g., prescription to Over-The-Counter      |
| > switch;                                                             |
| >                                                                     |
| > **Labeling Supplement** = all label change supplements required     |
| > under 21 CFR 314.70 and 21 CFR                                      |
| >                                                                     |
| > 601.12 that do not qualify as efficacy supplements;                 |
| >                                                                     |
| > **Chemistry, Manufacturing, and Controls Supplement** =             |
| > manufacturing change supplement                                     |
| >                                                                     |
| > submissions as provided in 21 CFR 314.70, 21 CFR 314.71, 21 CFR     |
| > 314.72 and 21 CFR 601.12;                                           |
| >                                                                     |
| > **Other** = any submission that does not fit in one of the other    |
| > categories (e.g., Phase IV response). If                            |
| >                                                                     |
| > this box is checked the type of submission can be explained in the  |
| > **REASON FOR SUBMISSION**                                           |
| >                                                                     |
| > block.                                                              |
| >                                                                     |
| > **Submission of Partial Application** Letter date of agreement to   |
| > partial submission should be                                        |
| >                                                                     |
| > provided. Also, provide copy of scheduled plan.                     |
| >                                                                     |
| > **CBE** \"Supplement-Changes Being Effected\" supplement submission |
| > for certain moderate changes for                                    |
| >                                                                     |
| > which distribution can occur when FDA receives the supplement as    |
| > provided in 21 CFR 314.70 and                                       |
|                                                                       |
| ## 21 CFR 601.12.                                                     |
+-----------------------------------------------------------------------+
| > **CBE-30** \"Supplement-Changes Being Effected in 30 Days\"         |
| > supplement submission for certain                                   |
| >                                                                     |
| > moderate changes for which FDA receives at least 30 days before the |
| > distribution of the product made                                    |
| >                                                                     |
| > using the change as provided in 21 CFR 314.70 and 21 CFR 601.12.    |
| >                                                                     |
| > **Prior Approval (PA)** \"Prior Approval Supplements\" supplement   |
| > submission for a major change for                                   |
| >                                                                     |
| > which distribution of the product made using the change cannot      |
| > occur prior to FDA approval as                                      |
| >                                                                     |
| > provided in 21 CFR 314.70 and 21 CFR 601.12.                        |
| >                                                                     |
| > **REASON FOR SUBMISSION** This section should contain a brief       |
| > explanation of the submission,                                      |
| >                                                                     |
| > e.g., \"manufacturing change from roller bottle to cell factory\"   |
| > or \"response to Information Request                                |
| >                                                                     |
| > Letter of 1/9/97\" or \"Pediatric exclusivity determination         |
| > request\" or \"to satisfy a subpart H                               |
| >                                                                     |
| > postmarketing commitment\".                                         |
| >                                                                     |
| > **NUMBER OF VOLUMES SUBMITTED** Please enter the number of volumes, |
| > including and                                                       |
| >                                                                     |
| > identifying electronic media, contained in the archival copy of     |
| > this submission.                                                    |
|                                                                       |
| ###### This application is                                            |
|                                                                       |
| > Paper Paper and Electronic Electronic                               |
| >                                                                     |
| > Please check the appropriate box to indicate whether this           |
| > submission contains only paper, both paper                          |
| >                                                                     |
| > and electronic media, or only electronic media.                     |
| >                                                                     |
| > **ESTABLISHMENT INFORMATION** This section should include           |
| > information on the locations of                                     |
| >                                                                     |
| > all manufacturing, packaging and control sites for both drug        |
| > substance and drug product. If                                      |
| >                                                                     |
| > continuation sheets are used, please indicate where in the          |
| > submission they may be found. For each                              |
| >                                                                     |
| > site please include the name, address, telephone number,            |
| > registration number (Central File Number),                          |
| >                                                                     |
| > Drug Master File (DMF) number, and the name of a contact at the     |
| > site. The manufacturing steps and/or type                           |
| >                                                                     |
| > of testing (e.g. final dosage form, stability testing) conducted at |
| > the site should also be included.                                   |
| >                                                                     |
| > Please indicate whether the site is ready for inspection or, if     |
| > not, when it will be ready. Please note                             |
| >                                                                     |
| > that, when applicable, the complete establishment description is    |
| > requested under item 15.                                            |
| >                                                                     |
| > **CROSS REFERENCES** This section should contain a list of all      |
| > License Applications,                                               |
| >                                                                     |
| > Investigational New Drug Applications (INDs), NDAs, Premarket       |
| > Approval Applications (PMAs),                                       |
| >                                                                     |
| > Premarket Notifications (510(k)s), Investigational Device           |
| > Exemptions (IDEs), Biological Master                                |
| >                                                                     |
| > Files (BMFs) and DMFs that are referenced in the current            |
| > application.                                                        |
| >                                                                     |
| > **Items 1 through 20 on the reverse side of the form** constitute a |
| > check list that should be used to                                   |
| >                                                                     |
| > indicate the types of information contained within a particular     |
| > submission. Please check all that                                   |
| >                                                                     |
| > apply. The numbering of the items on the checklist is not intended  |
| > to specify a particular order for                                   |
| >                                                                     |
| > the inclusion of those sections into the submission. The applicant  |
| > may include sections in any order,                                  |
| >                                                                     |
| > but the location of those sections within the submission should be  |
| > clearly indicated in the Index. It is                               |
| >                                                                     |
| > therefore recommended that, particularly for large submissions, the |
| > Index immediately follows the                                       |
| >                                                                     |
| > Form FDA 356h and, if applicable, the User Fee Cover Sheet (Form    |
| > FDA 3397).                                                          |
| >                                                                     |
| > The CFR references are provided for most items in order to indicate |
| > what type of information should                                     |
| >                                                                     |
| > be submitted in each section. For further information, the          |
| > applicant may consult the guidance                                  |
| >                                                                     |
| > documents that are available from the Agency.                       |
| >                                                                     |
| > **Signature** The form must be signed and dated. Ordinarily only    |
| > one person should sign the form, i.e.,                              |
| >                                                                     |
| > the applicant, or the applicant's attorney, agent, or other         |
| > authorized official. However, if the person                         |
| >                                                                     |
| > signing the application does not reside or have a place of business |
| > within the United States, the                                       |
| >                                                                     |
| > application should be countersigned by an attorney, agent, or other |
| > authorized official who resides or                                  |
|                                                                       |
| ## maintains a place of business within the United States.            |
+-----------------------------------------------------------------------+