http://www.fda.gov/cder/orange/appendix_a.txt 1/35 28, ETHINYL ESTRADIOL NABUMETONE, NABUMETONE NADOLOL, NADOLOL NAFAZAIR, NAPHAZOLINE HYDROCHLORIDE NAFCILLIN SODIUM, NAFCILLIN SODIUM NAFTIN, NAFTIFINE HYDROCHLORIDE NALBUPHINE HCL, NALBUPHINE HYDROCHLORIDE NALBUPHINE, NALBUPHINE HYDROCHLORIDE NALFON 200, FENOPROFEN CALCIUM NALFON, FENOPROFEN CALCIUM NALIDIXIC ACID, NALIDIXIC ACID APPENDIX A PRODUCT NAME INDEX NALLPEN IN PLASTIC...
Prescription and OTC Drug Product List 5/2002 2 -D- + ROBINS AH 325MG;15MG N84444 001 MAY DISC -A- @ 325MG;15MG N84444 001 MAY DISC SOLUTION; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE -D- AA ALPHARMA 120MG/5ML;12MG/5ML N85861 001 MAY CRLD -A- AA + 120MG/5ML;12MG/5ML N85861 001 MAY CRLD TYLENOL W/ CODEINE -D- AA + JOHNSON RW 120MG/5ML;12MG/5ML N85057 001 MAY DISC -A- @ 120MG/5ML;12MG/5ML N85057 001 MAY DISC TABLET; ORAL...
Prescription and Over-the-Counter Drug Product List: 6/2003 >D> AP + WYETH AYERST 5,000 UNITS/VIAL N17055 001 JUN DISC >A> @ 5,000 UNITS/VIAL N17055 001 JUN DISC >D> AP + 10,000 UNITS/VIAL N17055 002 JUN DISC >A> @ 10,000 UNITS/VIAL N17055 002 JUN DISC GUANABENZ ACETATE TABLET; ORAL GUANABENZ ACETATE >D> AB WATSON LABS EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >A> AB + EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >D> WYTENSIN ...
author: AUTHOR
Prescription and OTC Drug Product List 6/2002 -D- + WYETH AYERST 20,000 UNITS/VIAL N17055 003 JUN DISC -A- @ 20,000 UNITS/VIAL N17055 003 JUN DISC CHORIONIC GONADOTROPIN -D- + STERIS 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC -A- @ 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC GRANISETRON HYDROCHLORID E SOLUTION; ORAL KYTRIL -D- + ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27, 2001 JUN DISC -A- @ EQ 2MG BASE/10ML N21238...
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...
What's new at CDER by Date MedWatch Safety Information Draft Guidance: Providing Regulatory Submissions in Electronic Format - Content of Labeling [ Word ] or [ PDF ] Inactive Ingredient Database (updated) Orange Book Query January 30, 2004 Approval Times for Priority and Standard NDAs - Calendar Years 1993-2003 (updated) Consumer Drug Information Sheets Cialis Drug Shortages Current Drug Shortages : Solu-...
author: Paul Stauffer
Prescription and Over-the-Counter Drug Product List: 8/2003 4 >D> AA + ORTHO MCNEIL PHARM 300MG;60MG N85055 004 AUG DISC >A> @ 300MG;60MG N85055 004 AUG DISC ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> AA + MALLINCKRODT 500MG/15ML;10MG/15ML N40508 001 AUG 29, 2003 AUG NEWA >D> MIKART 500MG/15ML;5MG/15ML N81226 001 OCT 27, 1992 AUG CTEC >A> AA 500MG/15ML;5MG/15ML N81226 001 OCT 27, 1992 AUG...
author: AUTHOR
Prescription and OTC Drug Product List 10/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 325MG;7.5MG N40464 001 OCT 23, 2002 OCT NEWA -A- AA 325MG;10MG N40464 002 OCT 23, 2002 OCT NEWA -A- AA 650MG;10MG N40476 001 OCT 23, 2002 OCT NEWA -A- AA 750MG;7.5MG N40469 001 OCT 25, 2002 OCT NEWA -A- AA MALLINCKRODT 750MG...
Prescription and OTC Drug Product List 11/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 11: November 1999 [ Prescription - OTC ] - ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ALBUTEROL SULFATE BUPROPION HYDROCHLORIDE SOLUTION; INHALATION TABLET; ORAL ALBUTEROL SULFATE - ADD - BUPROPION HCL - ADD - AN MORTON GROVE EQ 0.083% BASE N75394 001 - ADD - AB...
Drug Approvals - M NDA 13-422/S-035 4/17/03 - - - Maxipime (Cefepime Hydrochloride) Injection,-Rx Bristol-Myers Squibb NDA 50-679/S-21 3/17/03 3/26/03 3/26/03 Maxipime (Cefepime Hydrochloride) Injection,- Bristol-Myers Squibb NDA 50-679/S-009, S-014 and S-018 8/21/02 8/26/02 - Maxipime (Cefepime Hydrochloride) Injection Bristol-Myers Squibb NDA 50-679/S007 1/27/99 - - 7/18/01 Maxitrol (neomycin ...
1996 and Older - New Drug Application (NDA) 20195/S-002 5/20/96 8/2/99 Fragmin/dalteparin sodium Injection [1.5 MB] Pharmacia and Upjohn 020287/S005 9/24/1996 2/4/1998 Heptolite, Kit for the Preparation of Technetium Tc 99m Disofenin Merck 18467/ S-13 & S-14 12/29/1993 8/5/2003 Humulin R Lilly 018870/S37 1/11/1994 6/17/2003 Hydrocortisone and Acetic Acid - Morton Grove Pharmaceuticals 040168 08/30/1996 8/1/2003 Hyzaar ...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt AMIODARONE HCL 3506 24-Apr-79 BAXTER ONCOLOGY GMBH IFOSFAMIDE 3507 27-Apr-79 GEDEON RICHTER LTD VINCRISTINE SULFATE 3513 08-Mar-79 FABBRICA ITALIANI SINTETICI SPA FUROSEMIDE 3516 30-Mar-79 DINAMITE DIPHARMA SPA TRIAMTERENE USP XIX/BP '73 3524 08-Feb-79 DINAMITE DIPHARMA SPA "CYPROHEPTADINE HCL, USP" 3529 30-May-79 AVENTIS PHARMA SA PREDNISOLONE ACETATE 3531 14-Mar-79 ...
Prescription and Over-the-Counter Drug Product List: 2/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL -A- CODRIX -A- + ANDRX PHARMS 500MG;15MG N40447 001 FEB 26, 2003 FEB NEWA AZATHIOPRINE TABLET; ORAL AZASAN -A- AAIPHARMA LLC 25MG N75252 002 FEB 03, 2003 FEB NEWA -A- AB 50MG N75252 001 JUN 07, 1999 FEB NEWA -A- 75MG N75252 003 FEB 03, 2003 FEB NEWA -A- 100MG N75252 004 FEB 03, 2003...
author: AUTHOR
Prescription and OTC Drug Product List 7/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE -A- AB ABLE 325MG;50MG;40MG N40390 001 JUL 23, 2001 JUL NEWA -A- AB 500MG;50MG;40MG N40394 001 JUL 23, 2001 JUL NEWA ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA + WATSON LABS 325MG;7.5MG...
SSCI Inc.: X-ray Powder Diffraction, Raman and Infrared Spectroscopy, Differential Scanning Calorimetry, and Thermogravimetric Phone: 800 375-2179 / 765 463-0112 Fax: 765 497-2649 / 765 463-4722 E-mail: info@ssci-inc.com SSCI Inc., 3065 Kent Avenue, West Lafayette, IN 47906 - 1076 USA Acetaminophen Acetazolamide Acetohexamide Acetylcysteine Acyclovir Adenine L-Alanine Albuterol Albuterol Sulfate Allopurinol Alprazolam Amantadine HCl Amiloride HCl Aminobenzoic Acid Aminoglutethimide Aminosalicylic Acid...
author: SSCI Webmaster
Prescription and OTC Drug Product List 8/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 8: August 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET; ORAL TABLET; ORAL - ADD - BUTALBITAL, ACETAMINOPHEN AND CAFFEINE MODURETIC 5-50 - ADD - AB MALLINCKRODT...
Prescription and OTC Drug Product List 6/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 6: June 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE AMINO ACIDS TABLET; ORAL INJECTABLE; INJECTION PERCOCET NOVAMINE 8.5% - ADD - AA ENDO PHARMS 325MG;5MG N40330 002 - DLT - @ PHARMACIA AND UPJOHN 8.5% N17957 002...
Prescription and OTC Drug Product List 1/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 1: January 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST PRESCRIPTION DRUG PRODUCT LIST 1 20TH EDITION ADDITIONS/DELETIONS FOR RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 1 / JAN'2000 - ADD - CALCIUM CHLORIDE CEFTIBUTEN DIHYDRATE - ADD -...
PDPL - ADD - + ADV MAGNETICS EQ 11.2MG IRON/ML N20416 001 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE - ADD - AUG 30, 1996 TABLET; ORAL-21 ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL 1/35-21 FLUPHENAZINE DECANOATE - DLT - AB WATSON LABS 0.035MG;1MG N72720 001 - DLT - DEC 30, 1991 INJECTABLE; INJECTION ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL 1/50-21 FLUPHENAZINE DECANOATE - DLT - AB WATSON...
Prescription Drug Product List 1/96 PRESCRIPTION DRUG PRODUCT LIST 16TH EDITION RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 1 / JAN'96 ACETAMINOPHEN; CODEINE PHOSPHATE CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE TABLET; ORAL - ADD - ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION; INTRAPERITONEAL - ADD - AA MIKART 300MG;60MG N89244 001 - ADD - DELFLEX W/ DEXTROSE 4.25% IN...
http://www.fda.gov/cder/rdmt/escy99ap.htm - - - - - - - - - - LEUPROLIDE ACETATE TAP HOLDINGS 20-708 04/13/98 02/11/99 SE8 5 N 10.0 Comparability demonstrated between 3.75 mg and 11.25 mg depot in the treatment of endometriosis and uterine fibroidsSULFATE 3M PHARMACEUTICALS 20-503 06/02/98 06/02/99 SE1 11 N 12.0 Provides for lowering the age from 12 years to 4 years and older for...
author: Darlene
Drug Approvals January 1997 Drug Approvals for January 1997 Definitions and Notes January 1997 Original New Drug Applications Original Application #: 050733 Approval Date: 30-JAN-97 Trade Name: ZITHROMAX Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: PFIZER INC Active Ingredient(s): AZITHROMYCIN OTC/RX Status: RX Indication(s): Treatment of patients with community-acquired...
http://www.plantsci.cam.ac.uk/plantsci/admin/forms/ChemCategD.pdf page 3 3 DOWEX ION EXCHANGE RESIN (INC. 50W- X8 STANDARD H+; CHLORIDE FORM; FORMATE FORM; MR- 3 AND MR- 12) ECL WESTERN BLOTTING REAGENTS (AMERSHAM) ECOSCINT A EDFS / ETHYLENEDIAMINETETRAACETIC ACID (FERRIC SODIUM SALT) EDTA / DIAMINOETHANETETRAACETIC ACID (free acid or sodium salts) EGTA / ETHYLENEGLYCOL- ...
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...
