http://www.fda.gov/cder/orange/appendix_a.txt 3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
Drug Approvals - B Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Bacitracin Injection, 50,000 units/vial, Rx American Pharmaceutical Partners ANDA 65-116 12/3/02 - - - Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP, Rx Altana, Inc
Drug Approvals - N ANDA 65-010 2/6/04 - Neomycin & Polymyxin B Sulfates & Bacitracin Zinc Ophthalmic Ointment USP, Rx Akorn, IncRx Novo Nordisk NDA 21-172/S9 11/18/02 11/22/02 11/19/02 NovoLog Mix 70/30- Injection, Rx Novo Nordisk NDA 21-172/S3 6/26/02 7/2/02 6/26/02 NovoLog Mix 70/30- Injection, Rx ...
Paddock Laboratories, Inc. - Other RX's BACITRACIN USP STERILE BELLADONNA & OPIUM SUPPOSITORIES COLISTIN SULFATE USP POWDER COLOCORT® Hydrocortisone Rectal Suspension, USP (Retention) COMPRO™ Prochlorperazine Suppositories, USP 25mg DEXAMETHASONE SODIUM PHOSPHATE USP POWDER HYDROCORTISONE ACETATE USP MICRONIZED POWDER HYDROCORTISONE ACETATE SUPPOSITORIES (Hemorrhoidal HC Suppositories) HYDROCORTISONE USP...
Paddock Laboratories, Inc. - Master Product List (Enteric-Coated Orange) OTC 0002-01 0002-11 325 mg - 100's 325 mg - U/D 100's - - - [B]--PRODUCTS-- Rx or OTC NDC 0574- Strength / Size MSDS Secundum Artem Issues Biblio- graphy Listing BACITRACIN USP STERILE Rx 0200-01 50,000 Units - - - BELLADONNA & OPIUM SUPPOSITORIES Rx Cll 7045-12 7040-12 7040-20 16.2 mg/30 mg - 12's 16.2 mg/60 mg - 12's 16.2 mg/60 mg -...
Paddock Laboratories, Inc. - Compounding Actives Antibiotic Powders Hormone Powders Steroid Powders ANTIBIOTIC POWDERS Bacitracin USP Micronized Powder 5 MU 0574-0400-05 Colistin Sulfate USP water soluble 1 BU 0574-0417-01 Paddock Nystatin Nystatin USP For Extemporaneous Preparation of Oral Suspension 50 MU 0574-0404-05 150 MU 0574-0404-15 500 MU 0574-0404-50 2 BU 0574-0404-02 HORMONE POWDERS Progesterone USP Micronized 10 GM...
FDA Drug Approvals List February 2002 Active Ingredient(s): BUSPIRONE HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Antibiotic Application#065022 Approval Date: 27-FEB-02 Trade Name: BACITRACIN ZINC AND POLYMYXIN B SULFATE Dosage Form: OINTMENT Applicant: ALTANA INC Active Ingredient(s): BACITRACIN ZINC; POLYMYXIN B SULFATE OTC/RX Status: RX Original Abbreviated Application# 075874 Approval...
510(k)s Final Decisions Rendered for April 2001 510(k) NO: K010956 (SPECIAL) ATTN: ANDREA L RUTH PHONE NO : 408-895-3625 2710 ORCHARD PARKWAY SE DECISION MADE: 13-APR-01 SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALIEN RX MICRO CANNULA, MODEL 4530 BOSTON SCIENTIFIC CORPRX HERCULINK PLUS...
author: CDRH/ODE
Prescription and OTC Drug Product List 5/2001 Prescription and Over-the-Counter Drug Product List - 21st Edition Cumulative Supplement Number 5: January-May 2001 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE - ADD - ALMOTRIPTAN MALATE CAPSULE; ORAL - ADD - TABLET; ORAL ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE - ADD - AXERT - DLT - + MIKART 150MG;180MG...
Prescription and OTC Drug Product List 2/2001 PEDIATRIC - ADD - @ 10MG;100MG N74080 001 - ADD - + ASTRAZENECA /1VIL;0.02MG/VIAL;0.001MG/VIAL; - ADD - MAR 25, 1994 - ADD - 5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL; - ADD - @ 25MG;100MG N74080 002 - ADD - 17MG/VIAL;0.2MG/VIAL; - ADD - MAR 25, 1994 - ADD - EQ 1MG BASE/VIAL;1.4MG/VIAL; - ADD - @ 25MG;250MG N74080 003 - ADD - EQ 1.2MG BASE/VIAL;0.7MG/VIAL; - ADD - MAR 25, 1994 - ADD - 7MG...
Drug Approvals for May 1997 orbiculare) Application #:020297Efficacy Supplement#:001 Type: SE1 to Original New Drug Application Approval Date: 29-MAY-97 Trade Name: COREG Dosage Form: TABLET Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS Active Ingredient(s): CARVEDILOL OTC/RX Status: RX Efficacy Claim: For the new indication of congestive heart failure and a new dosage strength of 3.125 mg Application #...
FDA Modernization Act of 1997 [DOCID: f:publ115.105] [[Page 2295]] FOOD AND DRUG ADMINISTRATION MODERIZATION ACT OF 1997 [[Page 111 STAT
http://www.fda.gov/cber/genadmin/fdamod97.txt FILE s830.enr --S.830-- S.830 One Hundred Fifth Congress of the United States of America AT THE FIRST SESSION Begun and held at the City of Washington on Tuesday, the seventh day of January, one thousand nine hundred and ninety-seven An Act To amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the regulation of food, drugs, devices, and...
http://www.fda.gov/cber/genadmin/fdamod97.pdf page 32
duplicates:http://www.fda.gov/cder/guidance/s830enr.pdf http://www.fda.gov/cdrh/modact97.pdf
FDA Drug Approvals List July 1999 Drug Approvals for July 1999 Definitions and Notes Original New Drug Applications Original Application #: 021057 Approval Date: 29-JUL-99 Trade Name: ANTAGON Chemical Type: 1 Therapeutic Potential: P Dosage Form: INJECTABLE Applicant: ORGANON INC Active Ingredient(s): GANIRELIX ACETATE OTC/RX Status: RX Indication(s): Provides for the inhibition of premature LH surges in women...
DDPA February 1996 Drug and Device Product Approvals for February 1996 ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 20-123 OMNISCAN NYCOMED GADODIAMIDE 05-FEB-96 (INJECTABLE) WAYNE, PA 287MG/ML (SUPPL-004) 19087 (NEW DOSAGE REGIMEN -- INCREASE OF CUMULATIVE DOSE TO 0.3MMOL/KG FOR MRI OF THE CNS IN ADULTS) 20-123 OMNISCAN NYCOMED GADODIAMIDE 05-FEB-96 (INJECTABLE) WAYNE, PA 287MG/ML (SUPPL...
bwe10d0.tmp CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: Application Number : 040145 Trade Name : WARFARIN SODIUM TABLETS USP Generic Name: Warfarin Sodium Tablets USP 1mg, 2mg, 2.5mg, 4mg, 5mg, 7.5mg and 10mg Sponsor : Barr LaboratoriesRx 1 _— — 12
author: fda
http://www.fda.gov/cder/da/ddpa92.wpd PAUL, MN MANUFACTURING SITE AICD SOFTWARE 55112-5798 MODULE 2830, VENTAK P MODEL 1600 PULSE GENERATOR 140-921 PREDNISTAB DOGS VET-A-MIX PREDNISOLONE 11-08-91 (TABLET) SHENANDOAH, IA 5MG 51601 ***SUPPLEMENTAL VETERINARY NADAs*** 138-792 MGA 100-200/ CATTLE UPJOHN MELENGESTROL ACETATE 02-12-92 RUMENSIN/TYLAN KALAMAZOO, MI 0.0000276-0.00022% (PELLETS) 49001 MONENSIN SODIUM 50-1200GM/TON...
