Teva Pharmaceutical Industries - News and PR - - Search Tevapharm: - - Press Release Teva Announces Approval of Tramadol HCl Tablets Jerusalem, Israel, June 20, 2002 - Teva Pharmaceutical Industries Ltd.Tramadol Hydrochloride Tablets, 50 mg.Tramadol Hydrochloride Tablets are the AB-rated generic version...
Paragraph IV Patent Certifications - DRUG NAME DOSAGE FORM STRENGTH RLD Acetaminophen Extended-release Tablets 650 mg Tylenol Acetaminophen/ Aspirin/ Caffeine Tablets 250 mg/250 mg/ 65 mg Excedrin (migraine) Acetaminophen and Tramadol Hydrochloride Tablets 325 mg/ 37.5 mg Ultracet Acyclovir Sodium1 Injection 50 mg/mL, 10 mL and 20 mL vials Zovirax Albuterol Sulfate Oral Syrup 2 mg(base)/ 5 mL Ventolin...
http://www.fda.gov/cder/orange/appendix_a.txt 4, ACETAMINOPHEN TYLENOL W/ CODEINE, ACETAMINOPHEN TYLENOL, ACETAMINOPHEN (OTC) TYLOX, ACETAMINOPHEN TYLOX-325, ACETAMINOPHEN TYMTRAN, CERULETIDE DIETHYLAMINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE TZ-3, TIOCONAZOLE (OTC) ** U ** U-CORT, HYDROCORTISONE ACETATE U-GENCIN, GENTAMICIN SULFATE UCEPHAN, SODIUM BENZOATE ULO, CHLOPHEDIANOL HYDROCHLORIDE ULTANE, SEVOFLURANE ULTIVA...
CDER Template - Replace Title Here Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - June 2002 - Generic Drug Name Generic Manufacturer Brand Name Approval Date- 1- AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, U 200 MG/28.5 MG (BASE)/5 ML, AND 400 MG/57 MG (BASE)/5 ML GENEVA PHARMACEUTICALS, INC
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FDA Drug Approvals List August 2001 JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE Active Ingredient(s): COPPER OTC/RX Status: RX Application #:018612 Labeling Supplement#: 026 To Original New Drug Application Approval Date: 24-AUG-01 Trade Name: NICORETTE Dosage Form: GUM, CHEWING Applicant: SMITHKLINE BEECHAM CONSUMER HEALTHCARE LP Active Ingredient(s): NICOTINE POLACRILEX OTC/RX Status: RX Application #: 014879 Labeling...
Prescription and OTC Drug Product List 2/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION; ORAL AUGMENTIN '400' -D- + GLAXOSMITHKLINE 400MG/5ML;EQ 57MG BASE/5ML N50725 002 MAY 31, 1996 FEB CRLD -A- 400MG/5ML;EQ 57MG BASE/5ML N50725 002 MAY 31, 1996 FEB CRLD AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL ...
ANDA 76-071 ANDA 75- 960 June 19, 2002 Purepac Pharmaceutical CoTramadol Hydrochloride Tablets, 50 mg
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ANDA 76-071 ANDA 75- 964 June 19, 2002 Caraco Pharmaceutical Laboratories, LtdTramadol Hydrochloride Tablets, 50 mg
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ANDA 76-071 ANDA 75- 968 June 25, 2002 Eon Labs, IncTramadol Hydrochloride Tablets, 50 mg
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ANDA 76-071 ANDA 75- 977 June 19, 2002 TEVA Pharmaceuticals USA Attention: Philip Erickson 1090 Horsham Road PTramadol Hydrochloride Tablets, 50 mg
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ANDA 76-071 ANDA 76- 003 June 20, 2002 CorePharma LLC Attention: Mukteeshwar Gande 215 Wood Avenue Middlesex, NJ 08846 Dear Sir: This is in reference to your abbreviated new drug application (ANDA) dated September 28, 2000, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Tramadol Hydrochloride Tablets, 50 mg
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ANDA 76-071 page 1
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ANDA 76-071 ANDA 76- 100 June 20, 2002 Mutual Pharmaceutical Company Attention: Robert Dettery 1100 Orthodox Street Philadelphia, PA 19124 Dear Sir: This is in reference to your abbreviated new drug application (ANDA) dated January 5, 2001, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Tramadol Hydrochloride Tablets, 50 mg
author: CDER USER
ANDA 76-071 page 1
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News & PR - TEVA Pharmaceutical Industries Ltd TEVA ANNOUNCES APPROVAL OF TRAMADOL HCL TABLETS Jerusalem, Israel, June 20, 2002 - Teva Pharmaceutical Industries LtdTramadol Hydrochloride Tablets, 50 mgTramadol Hydrochloride Tablets are the AB-rated generic version of RW Johnson’s Ultram ®O...
FDA Drug Approvals List December 1999 Active Ingredient(s): DILTIAZEM HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Application # 075406 Approval Date: 15-DEC-99 Trade Name: NORGESTREL AND ETHINYL ESTRADIOL Dosage Form: TABLET Applicant: SCS PHARMACEUTICALS Active Ingredient(s): NORGESTREL; ETHINYL ESTRADIOL OTC/RX Status: RX Original Abbreviated Application # 040262 Approval Date: 15-DEC-99 Trade Name:...
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 ...
Drug Approvals for November 1997 Drug Approvals for November 1997 Definitions and Notes November 1997 Original New Drug Applications Original Application #: 020652 Approval Date: 26-NOV-97 Trade Name: TESLASCAN Chemical Type: 1 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: NYCOMED INC Active Ingredient(s): MANGAFODIPIR TRISODIUM OTC/RX Status: RX Indication(s): As an adjunct to MRI to enhance the T1...
