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Food and Drug administration

Dockets Management Branch, 5630 Fishers Lane

Room 1061- HFA-305,

Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870

** [Questions -
Concerns](mailto:fdfadockets@oc.fda.gov?subject=petitions page)**

**CHRONOLOGICAL LIST OF PETITIONS AND ADVISORY OPINIONS**

**From January 1 to December 31, 2000**

**To view actual documents, make a note of the docket number. Click on**
<http://www.fda.gov/search.html>**, enter the docket number. You will
then get everything associated with that docket number.**

**\"65FR78494\" indicates a notice of some type was published in the
Federal Register (FR) for a particular date. The FR can be found at**
<http://www.fda.gov/ohrms/dockets/> **and then go to the Federal
Register section.**

**You can search this list by using the \"edit\" pull down menu and then
the \"find\" command from the above toolbar. Unfortunately, to make the
font (type) any larger will cause the text to wrap into the next line
and increase the length of the document.**

**DATE FILED DOCKET PETITIONER/SUBJECT MATTER DISPOSITION**

01/04/00 00P-0090 Pentech Pharmaceuticals Inc N1 65FR38562 6/21/00

Determine Paxil Oral Capsules not CP

withdrawn for safety reaso

01/04/00 00P-0091 Mitchall G Clark APPROVED 4/18/00

ANDA Suitability for Pamidronate CP

Disodium Injection

01/05/00 00P-0092 GensiaSicor Pharmaceuticals Approved 6/14/00

ANDA Suitability for Thiotepa for CP

Injection

01/05/00 99P-5589 Ethicon, Inc. Answered 9/4/01

Reclassification of Absorbable CCP

Polydioxanone Surgical Suture

01/07/00 00P-0110 Merck & Co. Inc. Denied 5/16/00

Add finasteride to priority section of CP

\"the List\"

01/10/00 00P-0117 Phoenix Scientific Inc Approved 3/9/00

ANADA Suitability for CP

Lincomycin-Spectinomycin Water Soluble

01/11/00 00P-0177 Robert Cohen pending

Request that FDA not Approve Upjohn\'s CP

Bovine Growth Hormone

01/18/00 00P-0219 Andrx Pharmaceuticals Inc. APPROVED 5/15/00

Verapamil Hydrochloride Extended-Release CP

Tablets

01/28/00 00P-0442 Ludlow Technical Products Approved 4/12/00

Variance from Perf Std for Electrode CP

Lead Wires & Patient Ca

01/31/00 00A-0355 Marcode WDL. per MT 3/21/01

Industrial Marking Equipment Regarding AP

Food Packing

02/01/00 00P-0443 Pace Medical Inc pending

Exempt Model 4220 Sterile Disposable CP

Surgical Extension Cabe

02/03/00 00P-0425 Mead Johnson INT 8/21/00

To amend 21 CFR 107 Subpart B,labeling CP

of infant formulas

02/03/00 99P-1589 Roxane Laboratories, Inc Approved 2/3/00

Stay effective date of approval for NDA PSA

20-932 Roxicodone

02/04/00 00P-0444 Phoenix Scientific Inc pending

ANADA Suitability for spectinomycin CP

sterile solution

02/04/00 98N-0044 Nutraceutical Corporation pending

Effect of dietary supplement on PRC

structure/function of body

02/04/00 00P-0499 Apotex Inc INT. 7/27/00, Denied 11/21/00

Review/Act on SKB \'132 Form C & \'423 CP

Form A patent for NDA20

02/07/00 00P-0497 Baxter Healthcare Corporation APPROVED 4/6/00

Exemption for the Baxter Volumetric CP

Catheters

02/07/00 00P-0498 Baxter Healthcare Corporation Pet denied 5/9/00

Exempt Swan-Ganz Pacing Catheters and CP

Probes

02/07/00 98N-0044 CRN & CHPA pending

Effect of dietary supplement on PSA

structure/function of body

02/07/00 98N-0044 CRN & CHPA pending

Effect of dietary supplement on PRC

structure/function of body

02/07/00 98N-0044 McNeil Consumer Healthcare 9/13/00

Effect of dietary supplement on PRC

structure/function of body

02/07/00 98N-0044 American Herbal Products Association pending

Effect of dietary supplement on PRC

structure/function of body

02/07/00 98N-0044 Grocery Manufacturers of America PRC5 DENIED 9/25/2000

Effect of dietary supplement on PRC

structure/function of body

02/07/00 00N-0506 Grocery Manufacturers of America PETITION DENIED
9/25/2000

Safety Issues Associated With Dietary PRC

Supplements

02/11/00 00P-0585 Lachman Consultant Services, Inc. N1 65FR 38561 6/2/00

Prozac (Fluoxetine) Tablets Voluntarily CP

Withdrawn

02/11/00 00P-0586 Natl Cheese Inst,Grocery Mfg of America WDL. 6/9/00

Amend Pt 133.3 re:Milk and Nonfat Milk CP

for use in Standardiz

02/12/00 00P-0653 The James Madison Project Answered 01/07/02

Amend the product insert &/or label for CP

Anthrax Vaccive adso

02/14/00 00P-0596 Phoenix Scientific, Inc, Closed

ANADA consisting of different physical CP

form of drug product

02/18/00 00P-0685 National Yogurt Association PART APP/PART DEN
9/13/2000

Revise of Yogurt Standards CP

02/24/00 00P-0787 Abbott Laboratories Pending

Electrode Lead Wires/Patient Cables of CP

21 CFR part 898

02/28/00 00P-0804 Thomas G. Crouthamel, Sr. DENIED 8/15/2000 (CLOSED)

FD&C Yellow #5 & FD&C Blue #1 Labeling CP

02/29/00 00P-0788 Advanced Neuromodulation Systems, Inc. DENIED
02/23/2001 (CLOSED)

Totally Implanted Spinal Cord Stimulator CCP

03/01/00 00P-0842 Thomas Blake, R.Ph. N1 65FR38561 6/21/00

Zantac 75 Effervescent Tablets CP

03/03/00 00P-0913 McDermott, Will & Emery APPROVED 6/13/00 (Closed)

ANDA suitability for Albuterol Sulfate CP

inhalation solution,

03/08/00 00P-0931 Perkin Elmer Wallac Inc. Pending

Wallac\'s Neonatal Biotinidase Kit, CCP

Models NB-1000, NB-4000

03/13/00 00P-1077 The Humane Society of the United States INT. 9/9/00

Amend Current Reg Banning Sale of Small CP

Turtles

03/13/00 00P-1084 Public Citizen\'s Health Group Pending

Diabetes Drugs CP

Troglitazone,rosiglitazone,pioglitazone

03/13/00 00P-1085 American Orthotic & Prosthetic Ass PART APP/DEN
9/13/2000

Classify cranial helment in class CP

I,exempt from premarket

03/13/00 00P-1117 Med Mira Laboratories Inc. NFR 65FR39098 6/23/00 EFF
8/3/00

Reclassify QuickAir Choke Reliever, CCP

Model 59-001A

03/14/00 00P-1120 UroSurge Pending

UroSurge Percutaneous SANS Device CCP

03/16/00 00P-1199 Biovail Corporation INT. 9/5/00

Approval of ANDAs for Extended-Release CP

03/17/00 78N-036L C.B. Fleet Company, Inc. ANS DTD 1/16/2001

OTC Laxative PRC

03/22/00 00P-1210 Occupational Knowledge International Part den/app
2/22/01 closed

Restrict Sale of Coal Tar-Containing CP

Products

03/22/00 00P-1211 Center for Food Safety Pending

Establish Mandatory Pre-Market Safety CP

Testing for GE Foods

03/23/00 00P-1213 Ferring Pharmaceuticals APPROVED 6/13/00 (Closed)

ANDA injectable formulation calcitonin CP

salmon (caltine)

03/24/00 92N-0297 U.S. Small Business Administration Pending

Prescription Drug Marketing Act of 1987, PRC

Drug Amds of 1992

03/24/00 88N-0258 U.S. Small Business Administration Pending

PRESCRIPTION DRUG MARKETING ACT OF 1987 PRC

GUIDELINE

03/31/00 00P-1225 Equi Aid Products, Inc. DENIED 6/30/00 (Closed)

ANADA Suitability for Ivermectin Liquid CP

for Horses

03/31/00 92N-0297 Pharmaceutical Distributors Association Withdrawn
4/8/02

Prescription Drug Marketing Act of 1987, PSA

Drug Amds of 1992

03/31/00 88N-0258 Pharmaceutical Distributors Association Withdrawn
4/8/02

PRESCRIPTION DRUG MARKETING ACT OF 1987 PSA

GUIDELINE

03/31/00 00P-1209 KaVo America Corporation NFR 4/7/00 65 FR 18234

Laser Flurescence Caries Detection CCP

Device

04/03/00 00P-1227 Center for Science in the Public Interes INT 9/13/2000

Amend Statements Made for Dietary CP

Supplements

04/06/00 75N-183H HFD-001 to Intnat\'l Lab Technology Corp INT. DTD
4/19/2001

Health-Care Antiseptic Drug Products for CP

OTC Human Use

04/07/00 00P-1243 Pharmaceutical Associates Inc. closed 4/26/00

ANDA Suitability for Hydrocodone CP

Bitartrate/Acetaminophen

04/07/00 00P-1240 CPR Medical Products Inc APPROVED 6/2/00 (Closed)

Variance from Perf Std for Electrode CP

Lead Wires & Patient Ca

04/11/00 00P-1245 Lachman Consultant Services, inc. APPROVED 4/17/01
(Closed)

ANDA for Nizatidine Capsules, 75mg CP

04/13/00 00P-1258 GE Marquette Medical Systems Inc et al APPROVED 5/5/00
(closed)

Standard for Electrode Lead Wires and CP

Patient Cables

04/18/00 92N-0412 Raj Matkari Notice of Final Order 6/13/00

Debarment of Raj Matkari; Notice of AST

Opportunity for Hearing

04/19/00 00P-1263 Genelabs Technologies, Inc Interim 10/17/00

Initiation of Procedure to Determine CP

Whether DHEA is exclude

04/21/00 00P-1265 Biosense Webster Inc APPROVED 5/9/00 (closed)

Performance standard for electrode lead CP

wires & patient cabl

04/25/00 00P-1270 King & Spalding APPROVED 9/9/2000

ANDA for combination oxycodone CP

hydrochloride/acetaminophen

04/26/00 83P-0187 Associated Pharmacologists & Toxicologis INT 10/10/00

REFRAIN FROM APPROVAL POLYURETHANE CP

CONTRACEPTIVE SPONGE

04/27/00 00P-1271 King & Spalding APPROVED 9/9/2000

Oxycodone hydrochloirde/acetaminophen CP

tablet 2.5mg/400mg;5.0

04/27/00 00N-0598 Grocery Manufacturers of America (GMA) Pending

Dietary Supplement Health CP

Claim/Implementation of Pearson De

05/02/00 00P-1279 Chattanooga Group Inc PAV & PDN IN PART 6/23/00
(Closed)

Extend the Compliance Dates for CP

Electrode Lead Wires and Pat

05/02/00 00P-1280 Abbott Laboratories NFR 1 65FR62285 10/18/2OOO

Exempt Devices Classified as Total CP

Triiodothyronine Test Sys

05/04/00 00A-1288 Daniel Kearns Pending

Bioburden, Environmental Monitoring AP

05/05/00 00P-1282 UrosMetrics Pending

EROS-Clitoral Therapy Device CCP

05/05/00 00P-1284 Grocery Mfrs of America et al Pending

General info for making claims ref about CP

lack of use of food

05/05/00 00P-1286 EP MedSystems, Inc. APPROVED 6/7/00 (Closed)

Performance standard for electrode lead CP

wires & patient cabl

05/08/00 99P-4613 Robert Cohen Pending

Revoke the Regulation That Approved PRC

Posilac

05/09/00 00P-1290 Prizm Medical, Inc. Denied 6/22/00

Performance standard for electrode lead CP

wire & patient cable

05/09/00 00P-1289 GensiaSicor Pharmaceuticals APPROVED 9/9/2000

Submission of supplement to abbreviated CP

new drug application

05/09/00 00P-1291 Pharmaceutical Assoc Inc DENIED 5/7/01 (Closed)

Opioid anagesic elixir drug product CP

suitable under an ANDA

05/10/00 00P-1292 Amrex-Zetron Inc DENIED 6/16/00 (Closed)

Performance Standard for Electrode Lead CP

Wires & Patient Cabl

05/11/00 00P-1275 Lipton Interim response 5/11/00

Health Claim: Vegetable oil sterol CP

esters & coronary heart d

05/11/00 98N-0044 Consumer Healthcare Products Assn Interim 11/9/00

Effect of dietary supplement on CP

structure/function of body

05/12/00 00P-1295 Accelerated Care Plus APPROVED 8/2/00 (Closed)

Performance Standard for Electrode Lead CP

Wires & Patient Cabl

05/17/00 00P-1297 Arnall Golden & Gregory, LLP Withdrawn 6/2/00

Permit an OTC drug mfg to include \"may CP

contain\" in label

05/19/00 00P-1304 Boston Scientific EP Technologies Approved 6/22/00

Variance from application of the CP

performance standard

05/22/00 00P-1308 Lachman Consultant Services, Inc. APPROVED 9/9/2000

Methimazole tablets USP,15mg/20mg are CP

suitable for ANDA

05/24/00 00P-1276 McNeil Consumer Healthcare Pending

Health Claim: Plant stanol esters and CP

heart disease

05/25/00 00P-1297 Arnall Golden & Gregory, LLP Interim 11/17/2000, App
11/5/01

Permit an OTC drug mfg to include \"may CP

contain\" in label

05/30/00 00P-1322 State of New York,MD,MI,WY,OH,TN,CT,VT,M INT. 11/22/00

Food Labeling and Allergen Contamination CP

Control

05/30/00 00P-1324 Mikart, Inc DENIED 4/30/01 (Closed)

Propoxyphene Napsylate/Acetaminophen 100 CP

Mg/500mg

05/30/00 00P-1330 University of Pennsylvania APP 12/11/00 & PDN part

Regulation approving the dosage approved CP

for drug Propecia

05/31/00 00P-1319 IOMED, Inc. Denied 6/22/00

Performance Standard for Electrode Lead CP

Wires & Patient Cabl

05/31/00 00P-1320 Allegiance Healthcare Corporation APPROVED (Closed)

Performance Standard for Electrode Lead CP

Wires & Patient Cabl

05/31/00 00P-1325 Aspirin Foundation of America Inc APP & DEN part
12/1/00 (Close

Declare Tylenol Arthritis Extended CP

Relief Misbranded

06/01/00 00N-0598 Durk Pearson and Sandy Shaw et al. Pending

Dietary Supplement Health CP

Claim/Implementation of Pearson De

06/01/00 00P-1326 American Seafood Distritutors Assoc Pending

Crabmeat; Amendment of Common or Usual CP

Name Regulation

06/01/00 00P-1342 Phoenix Scientific, Inc. Approved 8/15/2000

Minor change in a generic Pyrantel CP

Pamoate Paste

06/05/00 00P-1329 Arnall Golden & Gregory, LLP. INT. 11/29/00

Permit dietary supplement manufacturer CP

to include the phrase

06/13/00 00P-1340 Able Laboratories, Inc. INT. 12/12/00, Answered
05/24/01

Withdrawn of ROWASA Suppositories CP

06/13/00 00P-0586 NCI, NAPA & GMA pending

Amend Pt 133.3 re:Milk and Nonfat Milk CP

for use in Standardiz

06/15/00 00P-1343 E-Z-EM, Inc. NFR 65FR76930 12/8/00

Reclassify Barium Enema Retention CCP

Catheter to Class II

06/19/00 00P-1349 St. Jude Medical APPROVED 6/30/00 (Closed)

Variance for Electrode Lead Wires and CP

Patient Cables

06/20/00 00P-1352 GensiaSicor Pharmaceuticals Approved 1/16/01

ANDA Suitability Petition Camiodarone CP

Hydrochloride Injectio

06/21/00 00P-1355 Consumer Healthcare Products Assoc pending

Labeling requirements for dietary CP

supplements/St.John\'s wort

06/22/00 00P-1363 Iceberg Industries Corporation (Canada) Withdrawn
10/23/01

To Amend 21 CFR 165.110 to include a CP

Standard of Identity

06/23/00 00P-1365 Lachman Consultants Services Inc Approved 1/12/01

ANDA be submitted for Fluoxetine CP

Tablets/40 mg

06/23/00 00P-1419 Lachman Consultant Services Inc Approved 1/12/01

ANDA for Gabapentin Tablets 100 mg 300 CP

mg and 400 mg

06/27/00 00P-1369 CSPI DENIED 12/11/00 (Closed)

Prohibit Making an Unapproved Health CP

Claim

06/27/00 00P-1371 IOMED,Inc Pending:

Performance Standard for Electrode Lead CP

Wires and Patient

06/27/00 00P-1370 Medeva Pharmaceutical,Inc. INT. 12/20/00, Withdrawn
07/30/2003

ANDA for generic verions of Zaroxolyn CP

Tablets(metolazone

06/27/00 00P-1370 Medeva Pharmaceuticals, Inc INT. 12/20/00, Withdrawn
07/30/2003

ANDA for generic verions of Zaroxolyn PSA

Tablets(metolazone

06/28/00 00P-1372 Allegiance Healthcare Corporation Pending

Performance Standard for Electrode Lead CP

Wires & Patient Cabl

06/28/00 00P-1375 Lachman Consultant Services, inc. Pending

ANDA for Methimazole Tablets USP,20mg CP

06/29/00 00P-0787 Abbott Laboratories Pending

Electrode Lead Wires/Patient Cables of CP

21 CFR part 898

06/30/00 00P-1378 CTFA Pending

Cosmetic Products Containing Alpha CP

Hydroxy Acids

07/06/00 00P-1397 The Weinberg Group Inc APPROVED 4/17/01 (Closed)

Cefaclor Chewable Tablets 500mg ANDA CP

Suitability

07/14/00 00P-1406 Compressed Gas Assn/Nat Welding Supply pending

Stay Presenting, publishing promulgating PSA

\"Fresh Air\" Speeche

07/17/00 00P-1243 Pharmaceutical Assoc Inc (PAI) DENIED 5/7/01 (Closed)

ANDA Suitability for Hydrocodone CP

Bitartrate/Acetaminophen

07/18/00 00P-1411 CSPI Pending

Set a regulatory limit for methylmercury CP

in seafood

07/20/00 00P-1422 Yamanouchi Pharma Tecnologies Inc. APPROVED 4/17/01
(Closed)

Suitability Petition (OTC),Famotidine CP

Orally Disintegrating

08/01/00 00P-1431 Pharmaceuitcal Associates, Inc. CLOSED 8/30/00

ANDA for elixir containing 10mg CP

hydrocodone bitartrate/650mg

08/02/00 00P-1432 Paul Dowhal DENIED 8/17/01 (Closed)

Pregnancy Warning Language on OTC CP

Nicotine Products

08/03/00 00P-1433 Yamanouchi Pharma Technologies, Inc. Answered
07/31/2003

ANDA for OTC drug product Famotidine CP

orally disintegrating t

08/10/00 00P-1443 Zenith Goldline Pharmaceuticals Pending

Stay against approval of Alendronate PSA

Sodium Tablets

08/11/00 00P-1445 Zenith Goldline Pharmaceuticals INT. 2/2/01, Answered
07/31/2003

Paragraph IV ANDAs/180-Day Exclusivity CP

Purporses

08/11/00 00P-1446 Teva Pharmaceuitcals USA APPROVED 2/6/01 (Closed)

Mylan Nifedipine extented-release CP

tablets 30mg

08/14/00 00P-1452 Cook Imaging Corporation APPROVED 4/23/01 (Closed)

Supplement to Iopamidol Injection CP

08/17/00 00P-1462 Lachman Consultant Services Inc. APPROVED 2/13/01
(Closed)

Extend Phenytoin Sodium Capsules CP

08/18/00 00P-1466 Pfizer, Inc. INT. 2/2/01

Non-Approvable Letters for Neurontin CP

08/22/00 00P-1468 Lachman Consultant Services, Inc. Approved 7/3/02

ANDA for Sertraline Hydrochloride CP

Capsules 25mg, 50mg & 100m

08/22/00 00P-1265 Biosense Webster Inc Pending

Performance standard for electrode lead CP

wires & patient cabl

08/23/00 00P-1470 Baxter Healthcare Corporation Approved 1/11/01

ANDA 75-880 for 6%and10% CP

PremaSol-sulfite-free (Amino Acid)

08/23/00 00P-1471 GensiaSicor Pharmaceuticals DENIED 4/30/01 (Closed)

ANDA Suitability Petition Propofol CP

Injectable Emulsion 2%

08/23/00 00P-1472 Braintree Lab Inc DENIED 7/19/01 (Closed)

Over-the-counter sodium phosphate bowel CP

preparation products

08/28/00 75N-183H Woodward Laboratories, Inc. INT. 4/03/2001

Health-Care Antiseptic Drug Products for CP

OTC Human Use

08/29/00 00P-1486 Equi Aid Products, Inc DENIED 7/26/01 (CLOSED)

ANADA Suitability Petition for a Generic CP

Oral Ivermectin

08/30/00 00P-1491 Kraft Foods, Inc. INT 2/12/01

Amend Definition & Standard of Identy CP

for Parmesan Cheese

09/01/00 00P-1496 Lachman Consultant Services,Inc. Answered 6/20/2001

Gulucophage (Metformin HCI) Tablets, 625 CP

mg and 750mg,

09/05/00 00P-1500 Arnall Golden & Gregory LLP pending

Allow Dietary Supple Mfg to list CP

ingredients aphabetically

09/06/00 00P-1499 Public Citizen Answered 02/12/2004

Remove alosetron (Lotronex) from the CP

market

09/06/00 78N-0038 Ciba Specialty Chemicals Corporation Closed 4/19/02

Sunscreen Drug Products CP

09/06/00 00P-1518 PD Regulatory Services Inc withdrawn 2/14/01 (closed)

ANDA Suitability for Leucovorin Calcium CP

Injection 5mg/ML

09/08/00 00P-1329 Consumer Healthcare Products Assoc (CHPA INT.
3/17/2001

Permit dietary supplement manufacturer CP

to include the phrase

09/11/00 00P-1510 CTS Chemical Industries, LTD (Israel) Withdrawn
10/3/01

Establish safety of Echinacea extract as CP

a GRAS pharmaceutic

09/12/00 00P-1297 Consumer Healthcare Products Assoc (CHPA Approved
11/5/01

Permit an OTC drug mfg to include \"may CP

contain\" in label

09/15/00 00P-1519 Smart Drug Systems Inc APPROVED 12/7/00 (Closed)

ANADA for a generic new animal CP

drug/Heartgard chewable tblts

09/21/00 00P-1533 Cook MED Institute, Incorporated Pending

PTCA Balloon Catheters (74LOX) CCP

09/22/00 00P-1535 Boston Scientific Corporation DENIED 6/28/01 (Closed)

Biopsy forceps covers/non-electric CP

biopsy as Class I devices

09/29/00 00P-1548 Lachman Consultant Services, Inc. CLOSED 7/13/01

Neoral Soft Gelatin Capsules CP

10/02/00 00P-1551 Arnall Golden & Gregory, LLP Approved 1/16/01

Determine an ANDA may be submitted for a CP

propxphene Napsylat

10/02/00 00P-1550 Glaxo Wellcome DENIED 2/15/02 (Closed)

Approve ANDA for Cefuroxime Axetil CP

Products

10/02/00 00P-1551 Arnall Golden & Gregory, LLP Approved 1/16/01

Determine an ANDA may be submitted for a CP

propxphene Napsylat

10/02/00 00P-1550 Glaxo Welcome Inc DENIED 2/15/02 (Closed)

Approve ANDA for Cefuroxime Axetil PSA

Products

10/03/00 00P-1554 Baxter Healthcare Corp N1 65FR78494 12/15/00

Exempt pharmacy compounding CP

systems/Class II devices from PM

10/04/00 00P-1556 Hyman Phelps & McNamara PC Approved 02/27/2004

Policy regarding ANDA holder CP

confidentiality

10/10/00 00P-1560 Paul E. Knapp DENIED 3/30/01 (Closed)

Health Hazard of \"Radial\" Sunglasses CP

10/12/00 99P-4053 Mark P. Grath, Esq. DENIED 12/4/01 (Closed)

Sympathominetic Amine Phentermine PRC

10/13/00 00P-1564 Alcon Research LTD. Withdrawn 1/9/01

Grant a temporary exemption for one CP

packaging component

10/16/00 00P-1568 Lachman Consultant Services Inc Denied 7/9/02

ANDA Suitability Petition for Ursodiol CP

Oral Suspension

10/18/00 00P-1572 State of Alaska INT. 4/5/01

Adopt Standard of Identity for Bottled CP

Glacier Water,Blend

10/20/00 00P-1574 Recip AB, c/o R & R Registrations APPROVED 7/25/01
(Closed)

ANDA Suitability Petition for Potassium CP

Lodide 65 mg Tablets

10/20/00 00P-1577 GE OEC Medical Systems, Inc. Approved 1/18/01

Variance from source-skin distance CP

requirement of perf. std.

10/23/00 00P-1578 Michael R. Harbut, MD,MPH DENIED 3/30/01 (Closed)

Safety of Med.Devices Mfg. with Silicone CP

Catalyzed w/ Hexach

10/23/00 81N-0022 Public Citizen\'s Health Research Group INT. 1/18/01

OTC Weight Control Drug Products for CP

Human Use

10/23/00 76N-052N Public Citizen\'s Health Research Group INT. 1/18/01

OTC Nasal Decongestants CP

10/24/00 00P-1580 Lachman Consultant Services Inc Withdrawn 2/23/01
(closed)

Listed drug withdrawn from sale; Drug CP

product not marketed

10/25/00 95N-0304 American Herbal Products Assn et al INT. 4/20/01

Ephedrine Alkaloids: Reports of Adverse CP

Events; Availability

10/31/00 00P-1594 Highland Vet-Pharma, LLC DENIED 7/26/01 (Closed)

ANADA for Invermectin CP

11/03/00 00P-1600 SciReg, Inc. DENIED 7/26/01 (Closed)

ANADA Suitability for Ivermectin CP

11/03/00 00P-1603 American College of Obstetricians & Gyne INT. 4/26/01

Rescind Any Contraindications For Use of CP

Misoprostol In Preg

11/06/00 00P-1602 New Jersey General Assembly INT. 4/26/01

Remove Unapproved Children\'s Fluoride CP

Supplements from Mkt

11/07/00 00P-1607 Chemically Associated Neurological Disor DENIED
3/30/01 (Closed)

Revoke Implantation of Silicone CP

Gel-Filled Breast Implants

11/09/00 00P-1623 American College of OB-GYN (ACOG) CLOSED (SEE
00P-1603)

WDL of letter issued regarding product CP

Misoprostol

11/09/00 98P-0623 Levin Fishbein Sedran & Berman DENIED 5/11/01 (Closed)

Revoke determination that TSRH Pedicle PRC

Spinal Screw System

11/13/00 00P-1617 Ventro Corporation Withdrawn 1/3/01

Exemptions Requirements of 21 CFR CP

E-commerce Products

11/13/00 78N-0038 Playtex Products, Inc. Denied 5/24/01

Sunscreen Drug Products PSA

11/15/00 00P-1621 Lipomed, Inc. DENIED 8/1/01 (Closed)

ANDA suitability for cladribine-lipomed CP

10 mg/5ml

11/20/00 00P-1628 Anthron Bethea DENIED 9/19/01 (Closed)

Insurance Matters Regarding Unemployment CP

& Social Security

11/22/00 00A-1635 Advocacy, Incorporated Closed 4/3/01

Pharmacological Studies - Disability AP

Antidiscrimination

11/24/00 97N-0314 Jerome Stevens Pharmaceuticals Inc Denied 2/2/01

Prescription Drug Products; CP

Levothyroxine Sodium

11/29/00 00P-1641 Pharmaceutical Associates, Inc. APPROVED 4/17/01
(Closed)

ANDA Suitability for Combo Hydrocodone CP

Bitartrate & Acetamin

11/30/00 00P-1645 McKenna & Cuneo, L.L.P. APPROVED 4/17/01 (Closed)

ANDA for Mercaptopurine 100 mg Scored CP

Oral Tablet

12/04/00 00P-1648 NeuroControl Corporation Pending

Electrode Lead Wires and Patient Cables CP

12/05/00 00P-1668 CSPI PENDING

Action against mfrs&dists of garlic CP

supplements misbranded

12/06/00 00P-1655 HighlandVet-Pharma LLC APPROVED 1/29/01 (Closed)

ANADA Application; Proposed product CP

differ from appoved list

12/06/00 00P-1657 Cintas Corp. DENIED 3/12/2001 (CLOSED)

Request for exemption to allow phrase CP

\"may contain\" on conta

12/15/00 00P-1671 Pharmacists Planning Service, Inc. Pending

Patient Medicine Guides CP

(MedGuides)/Cox-II & NSAID

12/19/00 00P-1675 Biosite Diagnostics, Incorporated NFR1 66FR12733
2/28/2001

Triage B-Type Natriuetic Peptide (BNP) CCP

Test (K003475)

12/19/00 00P-1676 Southwest Texas State University Pending

Electrode Lead Wires and Patient Cables CP

12/20/00 00P-1687 Sartori Food Corp. CLOSED 5/17/02

Amend definition & standard of identity CP

for parmesan cheese

12/20/00 00P-1491 Sartori Foods Corporation .

Amend Definition & Standard of Identy CP

for Parmesan Cheese

12/21/00 00P-1680 Protein Technologies International, Inc. Pending

Amending the Method of Calculating CP

Protein Content