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 6/2002 45 -D- + NOVARTIS 1MG/ML N05929 001 JUN CAHN -A- XCEL PHARMS 1MG/ML N05929 001 JUN CAHN DILTIAZEM HYDROCHLORIDE INJECTABLE; INJECTION CARDIZEM -D- AP + AVENTIS PHARMS 5MG/ML N20027 001 OCT 24, 1991 JUN CAHN -D- + 25MG/VIAL N20027 003 AUG 18, 1995 JUN CAHN -A- AP + BIOVAIL 5MG/ML N20027 001 OCT 24, 1991 JUN CAHN -A- + 25MG/VIAL N20027 003 AUG 18, 1995 JUN CAHN DILTIAZEM MALATE;...
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...
Drug and Device Approvals March 1995 74-322 CAPTOPRIL NOVOPHARM CAPTOPRIL 20-MAR-95 (TABLET) WILSON, NC 12.5MG 27396 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) 74-434 CAPTOPRIL MYLAN CAPTOPRIL 22-MAR-95 (TABLET) MORGANTOWN, WV 12.5MG 26505 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) 74-451 CAPTOPRIL ROYCE LABS CAPTOPRIL 31-MAR-95 (TABLET) MIAMI, FL 12.5MG 33014 25MG 50MG 100MG (ANGIOTENSIN...
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...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt 4Q2003 TYPE2ACTIVETEXT DMF # SUBMIT DATE HOLDER SUBJECT 131 01-Jan-40 CENTRAL SOYA SOYBEAN STEROL PRODUCTS 183 29-Feb-52 INTERNATIONAL SPECIALTY PRODUCTS POLYVINYL PYRROLIDONE-IODINE 10 191 24-Jan-56 MALLINCKRODT CHEMICAL INC PARZONE BITARTRATE (DIHYDROCODEINE BITARTRATE) 240 11-Jan-57 PHARMACIA & UPJOHN 19-NOR-ETHINYLTESTOSTERONE 281 21-Nov-57 UNIMED PHARMACEUTICALS INC 2 HYDROXY...
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 LABS...
http://www.fda.gov/cder/rdmt/escy99ap.htm EFFICACY SUPPLEMENTS APPROVED IN CY 99 GENERIC NAME APPLICANT NDA NUMBER RECEIPT DATE APPROVAL DATE SUPP TYPE SUPP NUMBER PRIOITY REVIEW TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION - - - - - - - - - - ATOVAQUONE GLAXO WELLCOME 20-500 03/06/98 01/05/99 SE1 5 N 10.0 Prevention of Pneumocystis carinii pneumonia (PCP)SULFATE 3M...
author: Darlene
FDA Drug Approvals List August 1999 Original Application #: 020997 Approval Date: 05-AUG-99 Trade Name: CHIROCAINE Chemical Type: 2 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: DARWIN DISCOVERY LTD Active Ingredient(s): LEVOBUPIVACAINE HYDROCHLORIDE OTC/RX Status: RX Indication(s): For surgical anesthesia and pain management for adults Original Application #: 020902 Approval Date: 05-AUG-99 Trade Name:...
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...
RLD_LABELING_ APPROVED_AUG_1999 Product Name Drug Name NDA No Supp.No Firm Date LARIAM Mefloquine HCl Tablets 19-591 S-012 Roche 02-Aug-1999 PROSCAR Finasteride Tablets 20-180 S-018 Merck 02-Aug-1999 CEFOTAN Cefatetan Disodium 50-588 S-026 Zeneca 05-Aug-1999 MARINOL Dronabinol Capsules 18-651 S-011 Unimed 05-Aug-1999 ZOCOR Simvastatin Tablets 19-766 S-032 Merck 05-Aug-1999 GLUCOTROL Glipizide Tablets 17-783 S-015...
Drug Approvals - D NDA 21-041/S8 & S10 10/2/03 - 10/9/03 - - DepoCyt (Cytarabine Liposomal Injection), 10 mg/mL injection, Rx DepoTech Corporation NDA 21-041 4/1/99 4/5/99 4/5/99 7/5/02 Derma-Smoothe/FS (Fluocinolone Acetonide Topical Oil), Rx Hill Dermaceuticals, IncFluocinolone Acetonide Topical Oil), Rx Hill Dermaceuticals,...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls Arthur Shaw CDER User $ ($) $ ($) $ ($) $ ($) $ $ () $ - () - $ $ () $ - () - -- -- $ ($) $ ($) $ ($) $ ($) / / // -- - - : : :: : () () () () () - $ $ () $ - () - $ $ () $ - : :: : 4Q2003 TYPE2ACTIVEEXCEL DMF # SUBMIT DATE HOLDER SUBJECT CENTRAL SOYA SOYBEAN STEROL PRODUCTS INTERNATIONAL SPECIALTY PRODUCTS POLYVINYL PYRROLIDONE-IODINE 10 MALLINCKRODT CHEMICAL INC PARZONE BITARTRATE ...
OGD Suitability Tracking Reports (Sorted by Petition Number) as of 1/5/2004 - INJECTION Approved 8/13/2003- METHADONE HYDROCHLORIDE 15MG,20MG,30MG,40MG - 03P-0119/CP1 LACHMAN CONSULTANT SERVICES - TABLETS USP Pending 5/13/2003- VENLAFAXINE HYDROCHLORIDE 37.5MG, 75MG, 150MG - 03P-0159/CP1 LACHMAN CONSULTANT SERVICES - EXTENDED RELEASE TABLETS Pending 4/16/2003- DIVALPROEX SODIUM 1000 MG - 03P-0178/CP1 LACHMAN CONSULTANT SERVICES - EXTENDED RELEASE TABLETS...
OGD Suitability Tracking Reports (Sorted by Drug Name) as of 1/5/2004 - INJECTION Approved 8/13/2003- ESTROPIPATE 1.2 mg - 02P-0141/CP1 WOMEN FIRST HEALTHCARE - TABLETS Approved 9/24/2002- ETHINYL ESTRADIOL 0.035 MG NORETHINDRONE 0.4 MG - 99P-1150/CP1 KIRKLAND & ELLIS - TABLET; CHEWABLE Approved 4/14/2000- FAMOTIDINE 10MG - 00P-1422/CP1 YAMANOUCHI PHARMA TECHNOLOGIES - TABLET; ORALLY DISINTEGRATING Approved 4/17/2001- FENOFIBRATE 107 mg - 02P-0148/CP1...
FDA Drug Approvals List October 2001 - Drug Approvals for October 2001 Definitions and Notes Original New Drug Applications Original Application #: 021356 Approval Date: 26-OCT-01 Trade Name: VIREAD Chemical Type: 1 Therapeutic Potential: P Dosage Form: TABLET Applicant: GILEAD SCIENCES INC Active Ingredient(s): TENOFOVIR DISOPROXIL FUMARATE OTC/RX Status: RX Indication(s): For use in combination with other...
Prescription and OTC Drug Product List 1/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA KV PHARM 500MG/15ML;7.5MG/15ML N40366 001 JAN 23, 2002 JAN NEWA AMPHOTERICIN B INJECTABLE, LI COMPLEX; INJECTION ABELCET -A- + ELAN PHARMS 5MG/ML N50724 001 NOV 20, 1995 JAN CAHN -D- + LIPOSOME 5MG/ML N50724 001 NOV 20, 1995 JAN...
Prescription and OTC Drug Product List 10/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 10: October 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE BENZYL PENICILLOYL-POLYLYSINE CAPSULE; ORAL INJECTABLE; INJECTION BUTALBITAL, ACETAMINOPHEN AND CAFFEINE PRE-PEN - ADD - AB WEST WARD 500MG;50MG;40MG N40261...
