FDA Logo links to FDA home page
U.S. Food and Drug Administration
 HHS Logo links to Department of Health and Human Services website

FDA Home Page | Dockets Home Page | Dockets Contacts and Location | Operating Status

horizonal rule

Dockets Management
Dockets Entered On April 5, 2004
Table of Contents
Docket # Title
1977N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products
1994P-0036 Req labeling of trans fatty acid & prohibit deceptive claims
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
2000N-1652 Human Prescripton Drugs/Biologics in Electronic Format
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2002N-0204 Bar Code Label Requirements for human drug products
2002P-0406 ANDA Suitability for Amoxicillin & Clavulanate Potassium
2003H-0432 Civil Money Penalty, Korangy Radiology Associates, PA
2003N-0561 Orthopedic Devices; Effective Date of the Proposed Requirement for Premarket Approval of the Hip Joint Metal/Polymer or Ceramic/Polymer Semi-constrained Resurfacing Cemented Prosthesis
2003P-0366 Amend approval for a nonprescription form of Prilosec (omeprazole magnesium)
2004D-0041 Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Content of Labeling
2004N-0049 Agency Information Collection Activities; Proposed Collection; Comment Request; Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
2004N-0115 Prescription Drug Importation Study
2004P-0061 Take actions to establish guidance and clarify requirements for abbreviated new drug applications with regard to levothyroxine sodium products
2004P-0125 Sertraline hydrochloride tablets, 150 mg and 200 mg are suitable for submission in an ANDA
2004P-0140 Rescind the March 1, 2004 Dear Applicant Letter Regarding Metaxalone Labeling
2004P-0162 Zoloft (sertaline hydrochloride) Tablets 150 mg and 200 mg
1977N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products
SUP 47 Bayer HealthCare (Bayer) Vol #: 235
1994P-0036 Req labeling of trans fatty acid & prohibit deceptive claims
C 2610 W. Fontinel Vol #: 84
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 13524 EuroPharma, Inc. Vol #: 112
LET 13525 EuroPharma, Inc. Vol #: 112
LET 13526 EuroPharma, Inc. Vol #: 112
LET 13527 Enzymatic Therapy Natural Medicines Vol #: 112
LET 13528 Enzymatic Therapy Nautral Medicines Vol #: 112
LET 13529 Enzymatic Therapy Natural Medicines Vol #: 112
LET 13530 Enzymatic Therapy Natural Medicines Vol #: 112
LET 13531 Integrative Therapeutics Inc. Vol #: 112
LET 13532 AdvoCare International, L.P. Vol #: 112
LET 13533 Enzymatic Therapy Nautral Medicines Vol #: 112
LET 13534 Enzymatic Therapy Natural Medicines Vol #: 113
LET 13535 Lyco red Natural Products Industries, Ltd. Vol #: 113
LET 13536 Bayer Health Care consumer Care Division Vol #: 113
LET 13537 Enzymatic Therapy Natural Medicines Vol #: 113
LET 13538 Enzymatic Therapy Natural Medicines Vol #: 113
LET 13539 Enzymatic Therapy Natural Medicines Vol #: 113
LET 13540 Enzymatic Tehrapy Natural Medicines Vol #: 113
LET 13541 Enzymatic Therapy Natural Medicines Vol #: 113
LET 13542 Enzymatic Therapy Natural Medicines Vol #: 113
LET 13543 Enzymatic Therapy Natural Medicines Vol #: 113
LET 13544 Enzymatic Therapy Natural Medicines Vol #: 113
LET 13545 Perrigo Company of South Carolina Vol #: 113
LET 13546 Tianshi Health Products, Inc. Vol #: 113
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
C 7400 M. Cummings Vol #: 307
C 7401 A and B Powers Vol #: 307
2000N-1652 Human Prescripton Drugs/Biologics in Electronic Format
C 9 Bristol-Myers Squibb Company (BMS) Vol #: 1
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
EMC 5320 Lynne M Vol #: 200
EMC 5321 M. Fryer Vol #: 20
EMC 5322 T. Blake Vol #: 200
EMC 5323 R. Gittelman Vol #: 200
EMC 5324 K. Padilla Vol #: 200
EMC 5325 D. A. Jones Vol #: 200
EMC 5326 R. E. Joyce Vol #: 200
EMC 5327 S. Broidy Vol #: 200
EMC 5328 M. Smason Vol #: 200
EMC 5329 C. Becker Vol #: 200
EMC 5330 M. M. Hewitt Vol #: 200
EMC 5331 M. Trollinger Vol #: 200
EMC 5332 S. Dennis Vol #: 200
EMC 5333 L. Blinn Vol #: 200
EMC 5334 S. Clickner Vol #: 200
EMC 5335 A. Kahn Vol #: 200
EMC 5336 K. Gefeke Vol #: 200
EMC 5337 B. Gubb Vol #: 200
EMC 5338 C. Hill Vol #: 200
EMC 5339 J. Johns Vol #: 200
EMC 5340 J. King Vol #: 200
EMC 5341 L. Minneman Vol #: 200
EMC 5342 L. Price Vol #: 200
EMC 5343 C. Newton Vol #: 200
EMC 5344 S. Ping Vol #: 200
EMC 5345 V. Root Vol #: 200
EMC 5346 S.Hariri Vol #: 200
EMC 5347 J. Kobran Vol #: 200
EMC 5348 T. J. Fiorenza Vol #: 200
EMC 5349 J. H. Mayes Vol #: 200
EMC 5350 Mrs. Maraschino Vol #: 200
EMC 5351 K. A. DePaolo Vol #: 200
EMC 5352 E. Barr Vol #: 200
EMC 5353 M. T. Stahl Vol #: 200
EMC 5354 Tiffany L. Barlow Vol #: 200
EMC 5355 L. Dalton Vol #: 200
EMC 5356 S. R. Morris Vol #: 200
EMC 5357 K. Dean Vol #: 200
EMC 5358 E. McMillan Vol #: 200
EMC 5359 J. Dumont Vol #: 200
EMC 5360 M. Ranns Vol #: 200
EMC 5361 L. Hoffman Vol #: 200
EMC 5362 J. Schmidt Vol #: 200
EMC 5363 A. S.Dipietro Vol #: 200
EMC 5364 P. Gallo Vol #: 200
EMC 5365 R. Spaulding Vol #: 200
EMC 5366 D. Richardson Vol #: 200
EMC 5367 J. Meyer Vol #: 200
EMC 5368 J. McCollum Vol #: 200
EMC 5369 S. Moore Vol #: 200
EMC 5370 C. Laurenson Vol #: 200
EMC 5371 D. Caplan Vol #: 200
EMC 5372 L. Rivera Vol #: 200
EMC 5373 S. Kaye Vol #: 200
EMC 5374 J. Darrow Vol #: 200
EMC 5375 R. K. Benge Vol #: 200
EMC 5376 A. Sandoval Vol #: 200
EMC 5377 D. Fry Vol #: 200
EMC 5378 S. Soc Vol #: 200
EMC 5379 J. Rosenthal Vol #: 200
EMC 5380 R. Byers Vol #: 200
EMC 5381 W. L. Herzberg Vol #: 200
EMC 5382 J. Thobae Vol #: 200
EMC 5383 A. Rosenstein Vol #: 200
EMC 5384 M. Messeroff Vol #: 200
EMC 5385 R. Meyer Vol #: 200
EMC 5386 J. Woodman Vol #: 170
EMC 5387 J.Castro Vol #: 200
EMC 5388 D. Rio Vol #: 200
EMC 5389 M. McGath Vol #: 200
EMC 5390 L. Velez Vol #: 200
EMC 5391 J. H. Vol #: 200
EMC 5392 C. Mansell Vol #: 200
EMC 5393 C. Gilmore Vol #: 200
EMC 5394 G. Wallace Vol #: 200
EMC 5395 J. Delker Vol #: 200
EMC 5396 C.C. Elverston Vol #: 200
EMC 5397 C. Kane Vol #: 200
EMC 5398 M. Basart Vol #: 200
EMC 5399 D. Horn Vol #: 200
EMC 5400 C. Pares Vol #: 200
EMC 5401 J. Roche Vol #: 200
EMC 5402 K. Power-O'Brien Vol #: 200
EMC 5403 L. Maio Vol #: 200
EMC 5404 A. Hitch Vol #: 200
EMC 5405 D. Alden Vol #: 200
EMC 5406 M. Robinson Vol #: 200
EMC 5407 J. L. Jewell Vol #: 200
EMC 5408 A. West Vol #: 200
EMC 5409 J. Tietjen Vol #: 200
EMC 5410 A. Smith Vol #: 200
EMC 5411 G. & S. Davis Vol #: 200
EMC 5412 B. Adams Vol #: 200
EMC 5413 K. Keenan Vol #: 200
EMC 5414 M. Kobran Vol #: 200
EMC 5415 J. Blumenfeld Vol #: 200
EMC 5416 J. Swain-Bradway Vol #: 200
EMC 5417 A. Brewer Vol #: 200
EMC 5418 C. Kerr Vol #: 200
EMC 5419 R. Johnson Vol #: 200
EMC 5420 N. Washburn Vol #: 200
EMC 5421 R. Jupiter Vol #: 200
EMC 5422 W. Aalameh Vol #: 200
2002N-0204 Bar Code Label Requirements for human drug products
REF 3 OMB review for February 2, 2004 Vol #: 20
2002P-0406 ANDA Suitability for Amoxicillin & Clavulanate Potassium
WDL 1 The Weinberg Group, Inc. Vol #: 2
2003H-0432 Civil Money Penalty, Korangy Radiology Associates, PA
MO 5 GCF-1 Vol #: 2
MO 6 Korangey Radiology Associates, P.A., et al. Vol #: 2
SUM 1 Number not used Vol #: 2
2003N-0561 Orthopedic Devices; Effective Date of the Proposed Requirement for Premarket Approval of the Hip Joint Metal/Polymer or Ceramic/Polymer Semi-constrained Resurfacing Cemented Prosthesis
C 1 Orthopedic Surgical Manufacturers Assn (OSMA) Vol #: 1
2003P-0366 Amend approval for a nonprescription form of Prilosec (omeprazole magnesium)
C 3 The Procter & Gamble Company (P&G) Vol #: 1
2004D-0041 Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Content of Labeling
C 2 Bristol-Myers Squibb Company (BMS) Vol #: 1
C 3 Pharmaceutical Research and Manufacturers of America (PhRMA) Vol #: 1
C 4 Aventis Pharmaceuticals, Inc. (Aventis) Vol #: 1
2004N-0049 Agency Information Collection Activities; Proposed Collection; Comment Request; Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
C 2 Creating GreenPiece.com Vol #: 1
2004N-0115 Prescription Drug Importation Study
C 2 R. Brandt Vol #: 1
2004P-0061 Take actions to establish guidance and clarify requirements for abbreviated new drug applications with regard to levothyroxine sodium products
AMD 1 Jerome Stevens Pharmaceuticals, Inc. Vol #: 1
2004P-0125 Sertraline hydrochloride tablets, 150 mg and 200 mg are suitable for submission in an ANDA
WDL 1 Lachman Consultant Services, Inc. Vol #: 1
2004P-0140 Rescind the March 1, 2004 Dear Applicant Letter Regarding Metaxalone Labeling
LET 1 Corepharma, LLC Vol #: 1
2004P-0162 Zoloft (sertaline hydrochloride) Tablets 150 mg and 200 mg
ACK 1 HFA-305 to Lachman Consultant Services, Inc. Vol #: 1
CP 1 Lachman Consultant Services, Inc. Vol #: 1

Page created on April 6, 2004 dp
Page updated on April 19, 2004 rc

horizonal rule

Dockets Home| Dockets Contacts and Location | Operating Status | Item Code Definitions | Federal Register
FDA Home Page | Search FDA Site | A-Z Index | Contact FDA | Privacy | Accessibility

FDA/Dockets Management