72186 Federal Register / Vol. 79, No. 234 / Friday, December 5, 2014 / Notices 

applicant to assess whether they 

provide safety protections comparable 

to those in the applicable REMS 

ETASU. When the Agency has 

determined that comparable protections 

existed, FDA has issued letters to the 

RLD sponsor stating so, and indicating 

that FDA would not consider it to be a 

violation of the REMS for the RLD 

sponsor to provide drug product to the 

prospective ANDA applicant or its 

agent. 

Requesting or obtaining such a letter 

from FDA is not a legal requirement. If 

a prospective ANDA applicant chooses 

to request such a letter, this guidance is 

intended to clarify the process for doing 

so. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on how a prospective 

generic applicant can obtain a letter 

stating that its BE study protocols 

contain safety protections comparable to 

those in the applicable REMS for the 

RLD. It does not create or confer any 

rights for or on any person and does not 

operate to bind FDA or the public. 

II. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

III. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information that 

are subject to review by the Office of 

Management and Budget under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). The collections of 

information in 21 CFR parts 312 and 

314 have been approved under OMB 

control numbers 0910–0014 and 0910– 

0001. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http://www.

regulations.gov. 

Dated: December 1, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28540 Filed 12–4–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1795] 

Mallinckrodt Inc. et al.; Withdrawal of 

Approval of 23 New Drug Applications 

and 68 Abbreviated New Drug 

Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of 23 new drug applications 

(NDAs) and 68 abbreviated new drug 

applications (ANDAs) from multiple 

applicants. The holders of the 

applications notified the Agency in 

writing that the drug products were no 

longer marketed and requested that the 

approval of the applications be 

withdrawn. 

DATES: Effective Date: January 5, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Florine P. Purdie, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6248, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: The 

holders of the applications listed in 

table 1 in this document have informed 

FDA that these drug products are no 

longer marketed and have requested that 

FDA withdraw approval of the 

applications pursuant to the process in 

§ 314.150(c) (21 CFR 314.150(c)). The 

applicants have also, by their requests, 

waived their opportunity for a hearing. 

Withdrawal of approval of an 

application or abbreviated application 

under § 314.150(c) is without prejudice 

to refiling. 

TABLE 1 

Application No. Drug Applicant 

NDA 002852 ...... Plexofer (multivitamins) Syrup ................................................. Mallinckrodt Inc., 675 McDonnell Blvd., Hazelwood, MO 

63042. 

NDA 008719 ...... Levo-Dromoran (levorphanol tartrate) Injection, 2 milligrams 

(mg)/milliliter (mL).

Valeant Pharmaceuticals North America LLC, 400 Somerset 

Corporate Blvd., Bridgewater, NJ 08807. 

NDA 008720 ...... Levo-Dromoran (levorphanol tartrate) Tablets, 2 mg .............. Do. 

NDA 011777 ...... Sodium Phosphate P 32 Solution ............................................ Mallinckrodt Inc. 

NDA 012366 ...... Soma Compound with Codeine (carisoprodol, aspirin, and 

codeine phosphate).

Meda Pharmaceuticals Inc., 265 Davidson Ave., Suite 300, 

Somerset, NJ 08873–4120. 

NDA 012708 ...... Diutensen-R (methyclothiazide and reserpine) Tablets, 2.5 

mg/0.1 mg.

Do. 

NDA 016245 ...... Vercyte (pipobroman) Tablets .................................................. AbbVie, Inc., 1 North Waukegan Rd., Dept. PA 77/Bldg. 

AP30, North Chicago, IL 60064. 

NDA 017463 ...... Motrin (ibuprofen) Tablets, 300 mg, 400 mg, 600 mg, and 

800 mg.

McNeil Consumer Healthcare Division of McNeil-PPC, Inc., 

7050 Camp Hill Rd., Fort Washington, PA 19034–2299. 

NDA 018310 ...... Lymphazurin (isosulfan blue), 1% ............................................ Covidien, 60 Middletown Ave., North Haven, CT 06473. 

NDA 018340 ...... Aerobid (flunisolide) Inhalation Aerosol 1 ................................. Roche Palo Alto LLC, c/o Genentech Inc., 1 DNA Way, 

South San Francisco, CA 94080–4990. 

NDA 018731 ...... Buspar (buspirone hydrochloride (HCl)) Tablets, 5 mg, 10 

mg, 15 mg, and 30 mg.

Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 

08543–4000. 

NDA 019453 ...... Drixoral (dexbrompheniramine maleate, pseudoephedrine 

sulfate, and acetaminophen) Extended-Release Tablets, 3 

mg, 60 mg, and 500 mg.

Merck Consumer Care, 556 Morris Ave., Summit, NJ 07901. 


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TABLE 1—Continued 

Application No. Drug Applicant 

NDA 019842 ...... Motrin (ibuprofen) Suspension, 100 mg/5 mL ......................... McNeil Consumer Healthcare Division of McNeil-PPC, Inc. 

NDA 020150 ...... Nicotrol TD (nicotine transdermal system), 5 mg/16 hour (hr), 

10 mg/16 hr, and 15 mg/16 hr.

Do. 

NDA 020707 ...... Skelid (tiludronate disodium) Tablets ....................................... Sanofi-Aventis U.S. LLC, 55 Corporate Dr., Mailstop 55C– 

205A, Bridgewater, NJ 08807. 

NDA 021043 ...... RID Mousse (pyrethrins 0.33% and piperonyl butoxide 4.0%) 

Topical Aerosol.

Bayer Healthcare LLC, 100 Bayer Blvd., Whippany, NJ 

07981–0915. 

NDA 021082 ...... Tavist Allergy Sinus Headache (clemastine fumarate, 

pseudoephedrine HCl, and acetaminophen) Tablets, 0.335 

mg, 30 mg, and 500 mg.

Novartis Consumer Health, Inc., 200 Kimball Dr., Parsippany, 

NJ 07054. 

NDA 021190 ...... Buspar (buspirone HCl) Capsules, 5 mg, 7.5 mg, 10 mg, and 

15 mg.

Bristol-Myers Squibb Co. 

NDA 021335 ...... Gleevac (imatinib mesylate) Capsules, 50 mg and 100 mg ... Novartis Pharmaceuticals Corp., One Health Plaza, East

Hanover, NJ 07936. 

NDA 021745 ...... Ryzolt (tramadol HCl) Extended-Release Tablets, 100 mg, 

200 mg, and 300 mg.

Purdue Pharma Products L.P., One Stamford Forum, Stamford, CT 06901–3431. 

NDA 022217 ...... Valturna (aliskiren and valsartan) Tablets ............................... Novartis Pharmaceuticals Corp. 

NDA 022470 ...... Nexcede (ketoprofen) Oral Soluble Films, 12.5 mg ................ Novartis Consumer Health, Inc. 

ANDA 040034 .... Theophylline Extended-Release Tablets, 450 mg ................... Inwood Laboratories, Inc., Subsidiary of Forest Laboratories, 

Inc., Harborside Financial Center, Plaza Five, Suite 1900, 

Jersey City, NJ 07311. 

ANDA 040052 .... Theophylline Extended-Release Capsules, 100 mg, 125 mg, 

200 mg, and 300 mg.

Do. 

ANDA 040365 .... Dextroamphetamine Sulfate Tablets, 5 mg ............................. Nesher Pharmaceutical (USA) LLC, 13910 Saint Charles 

Rock Rd., Bridgeton, MO 63044. 

ANDA 040367 .... Dextroamphetamine Sulfate Tablets, 10 mg ........................... Do. 

ANDA 060578 .... Mycostatin Topical Powder (nystatin topical powder USP) 

100,000 units/gram (g).

Delcor Asset Corp., c/o Prestium Pharma Inc., 411 South 

State St., Suite E–100, Newtown, PA 18940. 

ANDA 062162 .... Erythromycin Estolate Capsules USP, 125 mg and 250 mg .. Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals 

USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677. 

ANDA 062256 .... Erythromycin Ethylsuccinate Tablets USP, 400 mg ................ Do. 

ANDA 062773 .... Cephalexin Capsules USP 250 mg ......................................... Do. 

ANDA 062850 .... Cephradine Capsules USP 250 mg ......................................... Do. 

ANDA 062851 .... Cephradine Capsules USP 500 mg ......................................... Do. 

ANDA 062858 .... Cephradine for Oral Suspension USP 125 mg/5 mL .............. Do. 

ANDA 062859 .... Cephradine for Oral Suspension USP, 250 mg/5 mL ............. Do. 

ANDA 063016 .... Cefazolin for Injection USP 250 mg/vial, 500 mg/vial, and 1 

g/vial.

Teva Pharmaceuticals USA, 425 Privet Rd., Horsham, PA 

19044. 

ANDA 063028 .... Erythromycin Delayed-Release Tablets USP, 333 mg ............ Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals 

USA. 

ANDA 063086 .... Erythromycin Delayed-Release Tablets, 333 mg .................... Do. 

ANDA 063098 .... Erythromycin Delayed-Release Capsules USP, 250 mg ........ Do. 

ANDA 063179 .... Erythromycin Stearate Tablets USP 500 mg ........................... ANI Pharmaceuticals, Inc., 210 Main St. West, Baudette, MN 

56623. 

ANDA 064191 .... Cefuroxime for Injection USP 7.5 g/vial ................................... Teva Pharmaceuticals USA. 

ANDA 064192 .... Cefuroxime for Injection USP 750 mg/vial and 1.5 g/vial ........ Do. 

ANDA 065032 .... Doxycycline Capsules USP 50 mg and 100 mg ..................... Sandoz Inc., 4700 Sandoz Dr., Wilson, NC 27893. 

ANDA 065227 .... Ceftriaxone for Injection USP, 250 mg/vial, 500 mg/vial, 1 g/

vial, and 2 g/vial.

Teva Pharmaceuticals USA. 

ANDA 065262 .... Ceftriaxone for Injection USP, 1 g/vial and 2 g/vial ................. Do. 

ANDA 065274 .... Ceftriaxone for Injection USP, 10 g/vial ................................... Do. 

ANDA 070034 .... Sulfamethoxazole and Trimethoprim Tablets USP 400 mg/80 

mg.

Teva Pharmaceuticals USA. 

ANDA 070216 .... Sulfamethoxazole and Trimethoprim Tablets USP 800 mg/

160 mg.

Barr Laboratories Inc., Subsidiary of Teva Pharmaceuticals. 

ANDA 072410 .... Indomethacin Extended-Release Capsules, 75 mg ................ Inwood Laboratories, Inc., Subsidiary of Forest Laboratories, 

Inc. 

ANDA 072499 .... Propranolol HCl Extended-Release Capsules, 60 mg ............ Do. 

ANDA 072500 .... Propranolol HCl Extended-Release Capsules, 80 mg ............ Do. 

ANDA 072501 .... Propranolol HCl Extended-Release Capsules, 120 mg .......... Do. 

ANDA 072502 .... Propranolol HCl Extended-Release Capsules, 160 mg .......... Do. 

ANDA 072619 .... Albuterol Sulfate Tablets USP 2 mg ........................................ Teva Pharmaceuticals USA. 

ANDA 072620 .... Albuterol Sulfate Tablets USP 4 mg ........................................ Do. 

ANDA 073095 .... Clemastine Fumerate Syrup, 0.5 mg/5 mL .............................. Do. 

ANDA 073531 .... Potassium Chloride Extended-Release Capsules USP, 8 

milliequivalents (mEq).

Do. 

ANDA 073532 .... Potassium Chloride Extended-Release Capsules USP, 10 

mEq.

Do. 

ANDA 073667 .... Nortriptyline HCl Capsules, 10 mg, 25 mg, 50 mg, and 75 

mg.

Do. 

ANDA 074043 .... Piroxicam Capsules USP, 10 mg and 20 mg .......................... Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., P.O. 

Box 4310, Morgantown, WV 26505. 


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72188 Federal Register / Vol. 79, No. 234 / Friday, December 5, 2014 / Notices 

TABLE 1—Continued 

Application No. Drug Applicant 

ANDA 074126 .... Atenolol Tablets USP, 25 mg, 50 mg, and 100 mg ................ Do. 

ANDA 074589 .... Minoxidil Topical Solution, 2% ................................................. Teva Pharmaceuticals USA. 

ANDA 074828 .... Acyclovir Capsules, 200 mg .................................................... Do. 

ANDA 074849 .... Clomipramine HCl Capsules, 25 mg, 50 mg, and 75 mg ....... Do. 

ANDA 074879 .... Ketoprofen Extended-Release Capsules, 200 mg .................. Alkermes Gainesville LLC, 1300 Gould Dr., Gainesville, GA 

30504. 

ANDA 074976 .... Acyclovir Tablets USP, 400 mg and 800 mg .......................... Mylan Pharmaceuticals, Inc. 

ANDA 074977 .... Acyclovir Capsules USP, 200 mg ............................................ Do. 

ANDA 075161 .... Ticlopidine HCl Tablets USP, 250 mg ..................................... Do. 

ANDA 075472 .... Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 

mg.

Do. 

ANDA 075934 .... Nizatidine Capsules USP, 150 mg and 300 mg ...................... Do. 

ANDA 076036 .... Quinapril Tablets USP, 5 mg, 10 mg, 20 mg, and 40 mg ....... Do. 

ANDA 076969 .... Metoprolol Succinate Extended-Release Tablets USP, 25 

mg, 50 mg, 100 mg, and 200 mg.

Sandoz, Inc. 

ANDA 077136 .... Terbinafine HCl Tablets, 250 mg ............................................. Mylan Pharmaceuticals, Inc. 

ANDA 077163 .... Sumatriptan Succinate Tablets, 25 mg, 50 mg, and 100 mg .. Do. 

ANDA 077254 .... Divalproex Sodium Delayed-Release Tablets USP, 125 mg, 

250 mg, and 500 mg.

Do. 

ANDA 077486 .... Glimepiride Tablets USP, 1 mg, 2 mg, and 4 mg ................... Do. 

ANDA 077705 .... Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/

12.5 mg and 20 mg/12.5 mg.

Do. 

ANDA 077934 .... Meloxicam Tablets USP, 7.5 mg and 15 mg ........................... Do. 

ANDA 077976 .... Cromolyn Sodium Nasal Solution USP, 5.2 mg/1 spray ......... HH & P LLC, c/o Kuker Regulatory Consulting, LLC, 18 Dunbar Way, Mahtomedi, MN 55115. 

ANDA 078638 .... Alendronate Sodium Tablets USP, 35 mg and 70 mg ............ Mylan Pharmaceuticals, Inc. 

ANDA 078731 .... Levetiracetam Tablets, 250 mg, 500 mg, 750 mg, and 1,000 

mg.

Do. 

ANDA 079184 .... Ursodiol Tablets USP, 250 mg and 500 mg ............................ Teva Pharmaceuticals USA. 

ANDA 081295 .... Estradiol Tablets USP, 0.5 mg ................................................ Bristol-Myers Squibb Co. 

ANDA 084499 .... Estradiol Tablets USP, 1 mg ................................................... Do. 

ANDA 084500 .... Estradiol Tablets USP, 2 mg ................................................... Do. 

ANDA 085794 .... Acetaminophen and Codeine Phosphate Tablets USP, 300 

mg/30 mg.

Mutual Pharmaceutical Co., Inc., 1100 Orthodox St., Philadelphia, PA 19124. 

ANDA 085795 .... Acetaminophen and Codeine Phosphate Tablets USP, 300 

mg/15 mg.

Do. 

ANDA 087176 .... Chlorthalidone Tablets USP, 50 mg ........................................ Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake, 

NJ 07677. 

ANDA 087653 .... Acetaminophen and Codeine Phosphate Tablets USP, 300 

mg/60 mg.

Mutual Pharmaceutical Co., Inc. 

ANDA 088833 .... Triprolidine HCl, pseudoephedrine HCl, and Codeine Phosphate Cough Syrup, 1.25 mg/5 mL, 30 mg/5 mL, and 10 

mg/5 mL.

Wockhardt Bio AG, c/o Morton Grove Pharmaceuticals, Inc., 

6451 Main St., Morton Grove, IL 60053. 

ANDA 088896 .... Promethazine VC with Codeine (promethazine HCl, phenylephrine HCl, and codeine phosphate) Cough Syrup, 6.25 

mg/5 mL, 5 mg/5 mL, and 10 mg/5 mL.

Do. 

NDA 202343 ...... Juvisync (sitagliptin and simvastatin) Tablets, 100 mg/10 mg, 

100 mg/20 mg, and 100 mg/40 mg.

Merck Sharp & Dohme Corp., 351 North Sumneytown Pike, 

P.O. Box 1000, UG2CD–015, North Wales, PA 19454. 

1This product included an oral pressurized metered-dose inhaler that contained chlorofluorocarbons (CFCs) as a propellant. CFCs may no 

longer be used as a propellant for any flunisolide metered-dose inhalers (see 75 FR 19213, April 14, 2010). 

Therefore, under section 505(e) of the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) (21 U.S.C. 355(e)) and 

under authority delegated to the 

Director, Center for Drug Evaluation and 

Research, by the Commissioner, 

approval of the applications listed in 

table 1 in this document, and all 

amendments and supplements thereto, 

is hereby withdrawn, effective January 

5, 2015. Introduction or delivery for 

introduction into interstate commerce of 

products without approved new drug 

applications violates section 301(a) and 

(d) of the FD&C Act (21 U.S.C. 331(a) 

and (d)). Drug products that are listed in 

Table 1 that are in inventory on the date 

that this notice becomes effective (see 

the DATES section) may continue to be 

dispensed until the inventories have 

been depleted or the drug products have 

reached their expiration dates or 

otherwise become violative, whichever 

occurs first. 

Dated: December 1, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28541 Filed 12–4–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with Section 

3507(a)(1)(D) of the Paperwork 


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