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...
Prescription and Over-the-Counter Drug Product List: 7/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE TABLET; ORAL PROPOXYPHENE HCL AND ACETAMINOPHEN >A> AA VINTAGE PHARMS 650MG;65MG N40507 001 JUL 30, 2003 JUL NEWA ACYCLOVIR TABLET; ORAL ACYCLOVIR >D> AB CLONMEL HLTHCARE 400MG N74834 001 APR 24, 1997 JUL DISC >A> @ 400MG N74834 001 APR 24, 1997 JUL DISC >D> AB 800MG N74834 002 APR 24,...
author: AUTHOR
FDA Drug Approvals List March 2001 Original Application #: 021082 Approval Date: 01-MAR-01 Trade Name: TAVIST ALLERGY/SINUS/HEADACHE Chemical Type: 4 Therapeutic Potential: S Dosage Form: TABLET Applicant: NOVARTIS CONSUMER HEALTH INC Active Ingredient(s): ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE OTC/RX Status: OTC Indication(s): For temporary relief of symptoms associated with hay fever,...
FDA Drug Approvals List May 2002 - Drug Approvals for May 2002 Definitions and Notes Original New Drug Applications Original Abbreviated Antibiotic Application # 065082 Approval Date: 31-MAY-02 Trade Name: CEFPODOXIME PROXETIL Dosage Form: GRANULE, FOR RECONSTITUTION Applicant: RANBAXY LABORATORIES LTD Active Ingredient(s): CEFPODOXIME PROXETIL OTC/RX Status: RX Original Application #: 021292 Approval Date: 31-MAY...
Prescription and OTC Drug Product List 11/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET; ORAL PERCOCET -A- + ENDO PHARMS 325MG;7.5MG N40434 001 NOV 23, 2001 NOV NEWA -A- + 325MG;10MG N40434 002 NOV 23, 2001 NOV NEWA ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE -A- AB ANABOLIC 325MG;50MG;40MG;30MG...
Drug and Device Approvals March 1995 Drug and Device Approvals-March 1995 ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 20-092 DILACOR XR RHONE POULENC RORER DILTIAZEM HYDROCHLORIDE 02-MAR-95 (CAPSULE, COLLEGEVILLE, PA 120MG (SUPPL-005)EXTENDED RELEASE) 19426 180MG 240MG (NEW INDICATION -- MANAGEMENT OF CHRONIC STABLE ANGINA) 20-281 ULTRAM JOHNSON RW TRAMADOL HYDROCHLORIDE 03-MAR-95 (TABLET) SPRING HOUSE,...
Inhaled corticosteroids for snoring - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Inhaled corticosteroids for snoring - [Medication] - Quest Diagnostics Patient Health Library Inhaled corticosteroids for snoring - [Medication] - Quest Diagnostics Patient Health Library Beclomethasone, Beconase, budesonide, Corticosteroid, Corticosteroids,...
Corticosteroids for sinusitis - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About Corticosteroids for sinusitis - [Medication] - Quest Diagnostics Patient Health Library Corticosteroids for sinusitis - [Medication] - Quest Diagnostics Patient Health Library beclomethasone dipropionate, Beconase, budesonide, Corticosteroid, Corticosteroids, Deltasone,...
Corticosteroids for allergic rhinitis - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Corticosteroids for allergic rhinitis - [Medication] - Quest Diagnostics Patient Health Library Corticosteroids for allergic rhinitis - [Medication] - Quest Diagnostics Patient Health Library Allergic, allergic disorder, Allergies, Allergy, beclomethasone...
BioPortfolio Limited Prescription Generics Report 2003 - 2011 1.
PowerPoint Presentation 2005 Annual Meeting of Shareholders March 17, 2005 Gerald J.
author: Amy Vavrunek
PowerPoint Presentation page 27
author: Amy Vavrunek
Reference Listed Drug Labeling Approved in March 2001 Mar 1 LUPRON DEPOT 7.5 mg letter label leuprolide acetate for injectable suspension 19-732 S-020 LUPRON DEPOT 3.75 mg letter label leuprolide acetate for injectable suspension 20-011 S-020 LUPRON DEPOT 3 month 11.25 mg letter label leuprolide acetate for injectable suspension 20-708 S-010 LUPRON DEPOT 4 month 30 mg letter label leuprolide acetate for injectable suspension 20-517 S...
author: USERNAME
Reference Listed Drug Labeling Approved in May 2002 -- COUMADIN letter -- warfarin Na tablet 09-218 SLR 098 - COUMADIN letter - warfarin Na tablet 09-218 SLR 099 May 3 DURICEF letter label cefadroxil monohydrate capsule 50-528 SLR 018 DURICEF letter label cefadroxil monohydrate suspension 50-527 SLR 020 DURICEF letter label cefadroxil monohydrate tablet 50-512 SLR 044 PREVACID letter label lansoprazole tablet 21-281 SLR 002 --...
author: USERNAME
Document Information Page DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 18- 148/ S- 030 and S- 035 NDA 20- 409/ S- 005 and S- 011 Ivax Research, Inc
author: CDER User
Document Information Page page 1
author: CDER User
