Drug Approvals - N Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Nabumetone Tablets, 500 mg, Rx- Second (Tentative Approval) Copley Pharmaceutical, Inc
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...
Reference Listed Drug Labeling Approved in June 2002 Approval Date Product Name - - Active Ingredient(s) Dosage Form NDA No Supp No -- TRIZIVIR -- letter label abacavir sulfate, lamivudine, zidovudine tablets 21-205 SLR 004 -Jun 4 CAFERGOT letter label ergotamine tartrate and caffeine suppositories 09-000 SLR 022 -- M.V.I.-12 letter - multi-vitamins for infusion injection 08-809 SLR 046 --- PEPCID injection letter label famotidine...
author: USERNAME
Prescription and Over-the-Counter Drug Product List: 6/2003 >D> AT ALLERGAN 1% N61187 001 JUN DISC >A> @ 1% N61187 001 JUN DISC >D> SOLUTION/DROPS; OPHTHALMIC >D> CHLOROPTIC >D> + ALLERGAN 0.5% N50091 001 JUN DISC >A> @ 0.5% N50091 001 JUN DISC >D> CHLOROQUINE HYDROCHLORIDE >D> INJECTABLE; INJECTION >D> ARALEN HCL >D> + SANOFI SYNTHELABO EQ 40MG BASE/ML N06002 002 JUN DISC >A> @ EQ 40MG BASE/ML N06002 002 JUN DISC CHLORPROMAZINE HYDROCHLORIDE...
author: AUTHOR
DOCUMENT INFORMATION PAGE N O N N N N N Co CN H H H H H H H NH COCH CH 2 2 2 2 2 NH COCH 2 2 2 2 2 2 NH COCH CH 3 CH 3 CH CH CH CONHCH 2 2 2 CH CH CONH 2 2 2 CH CH CONH 2 2 CH CONH 3 CH 3 CH 3 CH 3 CH 3 CH 3 CH 3 CH 3 CH 3 C O O O O P HO CH OH nascobal ® (Cyanocobalamin, USP) Gel for Intranasal Administration 500 mcg/ 0.1 mL Rx Only nascobal ® (Cyanocobalamin, USP) Gel for Intranasal...
author: ELEKWACHIO
subject: Approval Letter Nascobal Labeling
DOCUMENT INFORMATION PAGE page 2
author: ELEKWACHIO
subject: Approval Letter Nascobal Labeling
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author: ELEKWACHIO
subject: Approval Letter Nascobal Labeling
DOCUMENT INFORMATION PAGE page 1
author: ELEKWACHIO
subject: Approval Letter Nascobal Labeling
FDA Drug Approvals List June 2002 - Drug Approvals for June 2002 Definitions and Notes Original New Drug Applications Original Application # 021316 Approval Date: 26-JUN-02 Trade Name: ALTOCOR Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET Applicant: AURA LABORATORIES INC Active Ingredient(s): LOVASTATIN OTC/RX Status: RX INDICATION OF USE: For lowering total cholesterol and LDL-C to target levels as...
C:\labeling\NASCOBALs04ap.doc page 1
author: Kati Johnson
Drug Approvals November 1996 Drug Approvals for November 1996 Definitions and Notes November 1996 Original New Drug Applications Original Application #: 020397 Approval Date: 27-NOV-96 Trade Name: ZANAFLEX Chemical Type: 1 Therapeutic Potential: S Dosage Form: TABLET Applicant: ATHENA NEUROSCIENCES INC Active Ingredient(s): TIZANIDINE HYDROCHLORIDE OTC/RX Status: RX Indication(s): For the acute and intermittent...
Approved Products_2004.xls Number A pproval Date Trade Name Generic/ Chemical name Indication Company 1 Oct- 82 Humulin Human Insulin Type I Diabetes Lilly / Genentech 2 Oct- 85 Protro pin Human Growth Hormone Hypoptuitary dwarfism Genentech 3 Jun- 86 Intron A Interferon Al pha 2B Hairy Cell Leukemia Schering Plough / Biogen 4 Jun- 86 OKT- 3 Anti CD3 Mab Acute Trans plant Rejection JNJ / OrthoBiotech 5 Jun- 86...
author: Reijer
Approved Products_2004.xls page 2
author: Reijer
DOCUMENT INFORMATION PAGE page 2
author: ELEKWACHIO
subject: Approval Letter Nascobal Labeling
Future Leaders in the Biotech Industry, Spring 2003 A Collaborative Gathering of the Corporate and Investment Communities - Organized By With the Support of Gold Sponsors Silver Sponsor Contributing Sponsors Joined by BioCentury & Thomson Financial/Carson Present The 10th Anniversary of The 20th Clear Route to ROI Investment Conference Thursday, April 3, 2003 Millennium Broadway Hotel & Conference Center New York City Review the...
971024 Del rsrapport januari - september 1997 eng page 2
author: cb
subject: 971024 Del rsrapport januari - september 1997 eng
980126 Prelimin r bokslutsrapport 1997 eng Interim report on 1997 the financial year Preliminary report on the financial year Meda AB (publ) · Sales decreased marginally to total SEK 496 (497) M
author: cb
subject: 980126 Prelimin r bokslutsrapport 1997 eng
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author: cb
subject: 980126 Prelimin r bokslutsrapport 1997 eng
980126 Prelimin r bokslutsrapport 1997 eng Report on the financial year Report on the 1997 financial year Meda AB (publ) · Sales decreased marginally to total SEK 496 (497) M
author: cb
subject: 980126 Prelimin r bokslutsrapport 1997 eng
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author: cb
subject: 980126 Prelimin r bokslutsrapport 1997 eng
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author: cb
subject: 980126 Prelimin r bokslutsrapport 1997 eng
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author: cb
subject: 980126 Prelimin r bokslutsrapport 1997 eng
