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 Over-the-Counter Drug Product List: 5/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, APAP, AND CAFFEINE -A- AB AXIOM PHARM 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN -D- AB HALSEY 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 500MG;7.5MG...
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Microsoft Word - WMA89098.DOC 7261326 STERILE OPHTHALMIC SOLUTION NEODECADRON ® (NEOMYCIN SULFATEDEXAMETHASONE SODIUM PHOSPHATE) DESCRIPTION Ophthalmic Solution NEODECADRON * (Neomycin Sulfate- Dexamethasone Sodium Phosphate) is a topical corticosteroid- antibiotic solution for ophthalmic use
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Microsoft Word - WMA89098.DOC page 5
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Microsoft Word - WMA89098.DOC page 4
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Microsoft Word - WMA89098.DOC page 3
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Microsoft Word - WMA89098.DOC page 2
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Microsoft Word - WMA89098.DOC page 1
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Prescription and OTC Drug Product List 12/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 12: December 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - ADD - ABACAVIR SULFATE ALBUTEROL SULFATE - ADD - SOLUTION; ORAL SOLUTION; INHALATION - ADD - ZIAGEN ALBUTEROL SULFATE - ADD - + GLAXO WELLCOME EQ 20MG BASE/ML N20978 001 -...
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...
DDPA November 1995 74-493 CAPTOPRIL PAR CAPTOPRIL 14-NOV-95 (TABLET) SPRING VALLEY, NY 12.5MG 10977 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 19-543 ELOCON SCHERING MOMETASONE FUROATE 03-OCT-95 (OINTMENT) KENILWORTH, NJ 0.1% 07033 (LABELING REVISION -- INDICATIONS AND USAGE; PRECAUTIONS; ADVERSE REACTIONS; DOSAGE AND ADMINISTRATION) 19-625...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt OF IRELAND" 13266 05-Oct-98 FABBRICA ITALIANA SINTETICI SPA "NITROFURANTOIN MONHYDRATE, MANUFACTURED IN VICENZA, ITALY" 13277 22-Oct-98 MATRIX LABORATORIES LIMITED "ACYCLOVIR USP, MANUFACTURED IN ANDHRA PRADESH, INDIA" 13279 19-Oct-98 SYLACHIM DIV FINORGA "LEVOBETAXOLOL HYDROCHLORIDE, MANUFACTURED IN CHASSE-SUR-RHONE, FRANCE" 13282 15-Oct-98 DAICEL CHEMICAL INDUSTRIES LTD "CHIRALPAK...
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...
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Guideline on Validation of the Limulus Amebocyte Lysate Test As An End-Product Endotoxin Text for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices Bulk, Group C Meningococcal Polysaccharide Vaccine Group A Meningococcal Polysaccharide Vaccine Group C Meningococcal Polysaccharide Vaccine Group A and C Menotropin Meperidine HCl Injection Mephentermine Sulfate Mepivacaine HCl Mepivacaine HCl and Levonordefrin Meprobamate Injection Meprylcaine HCI and Epinephrine Mercaptomerin Sodium Mersalyl with theophylline Merethoxylline...
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subject: December 1987 Guideline
Prescription and OTC Drug Product List 1/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 1: Jan 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACARBOSE ALPROSTADIL TABLET; ORAL INJECTABLE; INJECTION PRECOSE PROSTIN VR PEDIATRIC - DLT - @ BAYER 25MG N20482 004 - DLT - + PHARMACIA AND UPJOHN 0.5MG/ML N18484 001 - DLT - MAY 29, 1997 - ADD -...
Prescription and OTC Drug Product List 12/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 12: December 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE - ADD - BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE TABLET; ORAL - ADD - GEL; TOPICAL OXYCODONE AND ACETAMINOPHEN - ADD - BENZACLIN - ADD - AA WATSON...
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 -...
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...
DDPA October 1995 19-672 EFIDAC 24 ALZA BROMPHENIRAMINE MALEATE 20-OCT-95 PSEUDOEPHEDRINE/ PALO ALTO, CA 16MG BROMPHENIRAMINE 94303 PSEUDOEPHEDRINE (TABLET, HYDROCHLORIDE EXTENDED RELEASE) 240MG (ANTIHISTAMINE/DECONGESTANT) (OTC) 20-520 ZANTAC 75 GLAXO WELLCOME RANITIDINE HYDROCHLORIDE 23-OCT-95 (TABLET) RES TRIANGLE PK, NC EQ 75MG BASE 27709 (HISTAMINE H-2 RECEPTOR ANTAGONIST) (OTC) 20-298 ZYLOPRIM...
DDPA September 1995 50-685 CEDAX SCHERING PLOUGH CEFTIBUTEN DIHYDRATE 07-SEP-95 (CAPSULE) KENILWORTH, NJ EQ 400MG BASE 07033 (CEPHALOSPORIN) 50-686 CEDAX SCHERING PLOUGH CEFTIBUTEN DIHYDRATE 07-SEP-95 (POWDER, KENILWORTH, NJ EQ 90MG BASE/5ML FOR ORAL 07033 EQ 180MG BASE/5ML SUSPENSION) (CEPHALOSPORIN) 20-498 CASODEX ZENECA BICALUTAMIDE 14-SEP-95 (TABLET) WILMINGTON, DE 50MG 19850 (ANTIANDROGEN) [USE IN...
Prescription and OTC Drug Product List 1/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 1: January 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE BENDROFLUMETHIAZIDE; NADOLOL CAPSULE; ORAL TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN CORZIDE - ADD - AA MALLINCKRODT 500MG;5MG N88956 001 - ADD -...
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