http://www.fda.gov/cder/orange/appendix_a.txt 3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt 6862 02-Mar-87 MITSUBISHI INTERNATIONAL CORP CLEMASTINE FUMERATE (CO-HELD BY DAITO KOEKI KABUSHIKI KAISHA TOYOMA) 6863 10-Mar-87 CUNO INC "100 TSM MEDIA CARTRIDGES AS MFGCLEMASTINE FUMERATE MANUFACTURED IN JAPAN
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
ANDAs Approvals - November 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office Of Generic Drugs ANDAs Approvals-November 2000 Page: 1 1
author: USERNAME
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...
Prescription and OTC Drug Product List 11/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 11: November 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE CLOBETASOL PROPIONATE TABLET; ORAL OINTMENT; TOPICAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN EMBELINE - ADD - ENDO PHARMS 400MG;5MG N40288 001 - ADD - AB...
Prescription and OTC Drug Product List 11/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 11: November 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - ADD - ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE AMOXICILLIN - ADD - TABLET; ORAL TABLET; ORAL - ADD - TRIZIVIR AMOXICILLIN - ADD - + GLAXO WELLCOME EQ 300MG BASE;150MG;300MG N21205 001 - ADD -...
Prescription and OTC Drug Product List 1/2001 Prescription and Over-the-Counter Drug Product List - 21st Edition Cumulative Supplement Number 1: January 2001 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET; ORAL TABLET; ORAL - ADD - ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE...
PDPL - ADD - AB1 0.6MG/HR N89774 001 - DLT - SEARLE 0.35MG N17060 001 - ADD - AUG 30, 1996 - ADD - NOR-QD NITRO-DUR - ADD - + SEARLE 0.35MG N17060 001 - DLT - BX + KEY PHARMS 0.1MG/HR N20145 001 - DLT - APR 04, 1995 - DLT - BX + 0.2MG/HR N20145 002 NYSTATIN - DLT - APR 04, 1995 - DLT - BX + 0.4MG/HR N20145 004 POWDER; TOPICAL - DLT - APR 04, 1995 MYCOSTATIN - DLT - BX + 0.6MG/HR N20145...
FDA Drug Approvals List- March 1998 Drug Approvals for March 1998 Definitions and Notes March 1998 Original New Drug Applications Original Application #: 020827 Approval Date: 30-MAR-98 Trade Name: MONISTAT 3 Chemical Type: 3 Therapeutic Potential: S Dosage Form: CREAM Applicant: ADVANCED CARE PRODUCTS Active Ingredient(s): MICONAZOLE NITRATE OTC/RX Status: OTC Indication(s): For the over-the-counter treatment of...
FDA Drug Approvals List November 2000 - Drug Approvals for November 2000 Definitions and Notes Original New Drug Applications Original Application #: 050782 Approval Date: 27-NOV-00 Trade Name: TRADENAME Chemical Type: 3 Therapeutic Potential: S Dosage Form: GEL Applicant: TARGET RESEARCH ASSOCIATES Active Ingredient(s): CLINDAMYCIN PHOSPHATE OTC/RX Status: RX Indication(s): FOR ONCE A DAY TREATMENT OF ACNE VULGARIS...
http://www.fda.gov/cder/foi/appletter/2000/75703ltr.pdf ANDA 75- 703 November 27, 2000 Apotex CorpClemastine Fumarate Syrup, 0.5 mg (base)/ 5 mL
http://www.fda.gov/cder/foi/appletter/2000/75703ltr.pdf page 1
DDPA November 1995 20-469 BECLOMETHASONE SCHERING BECLOMETHASONE DIPROPIONATE 09-NOV-95 DIPROPIONATE KENILWORTH, NJ MONOHYDRATE MONOHYDRATE 07033 EQ 0.084MG DIPROP/INH (SPRAY, METERED) (STEROID) 20-539 LAMISIL SANDOZ TERBINAFINE HYDROCHLORIDE 21-NOV-95 (TABLET) EAST HANOVER, NJ EQ 250MG BASE 07936 (ANTIFUNGAL) 20-291 COMBIVENT BOEHRINGER INGELHEIM ALBUTEROL SULFATE 22-NOV-95 (AEROSOL, METERED)...
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...
DDPA August 1996 DEPARTMENT OF HEALTH AND HUMAN SERVICES, PUBLIC HEALTH SERVICE NDA NUMBER TRADE NAME APPLICANT ACTIVE INGREDIENT(S) APPROVAL DATE (DOSAGE FORM) STRENGTH(S) (CLASSIFICATION) CLASSIFICATION(S) ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 19-640 HUMATROPE LILLY SOMATROPIN, BIOSYNTHETIC 01-AUG-96 (INJECTABLE) INDIANAPOLIS, IN 5MG/VIAL (SUPPL-013) 45285 (NEW INDICATION --...
Drug Approvals October 1996 Drug Approvals for October 1996 Definitions and Notes October 1996 Original New Drug Applications Original Application #: 019821 Approval Date: 28-OCT-96 Trade Name: SORIATANE Chemical Type: 2 Therapeutic Potential: S Dosage Form: CAPSULE Applicant: HOFFMAN-LAROCHE Active Ingredient(s): ACITRETIN OTC/RX Status: RX Indication(s): Treatment of severe psoriasis Original Application #:...
August Drug Approvals Original Application #: 020508 Approval Date: 29-AUG-96 Trade Name: LAC-HYDRIN Chemical Type: 3 Therapeutic Potential: S Dosage Form: CREAM Applicant: BRISTOL MYERS CO Active Ingredient(s): AMMONIUM LACTATE OTC/RX Status: RX Indication(s): ICHTHYOSIS VULGARIS AND XEROSIS Original Application #: 020532 Approval Date: 26-AUG-96 Trade Name: IVY BLOCK Chemical Type: 1 Therapeutic...
Drug Approvals for December 1997 Also provides for the addition of Haemophilus influenzae to the presently approved indication for secondary bacterial infections of acute bronchitis Application #: 020522 Efficacy Supplement#: 004 Type: SE1 to Original New Drug Application Approval Date: 17-DEC-97 Trade Name: NUTROPIN AQ Dosage Form: INJECTABLE Applicant: GENENTECH INC Active Ingredient(s): SOMATROPIN, BIOSYNTHETIC...
Drug Approvals for October 1997 Drug Approvals for October 1997 Definitions and Notes October 1997 Original New Drug Applications Original Application #: 020755 Approval Date: 31-OCT-97 Trade Name: CAVERJECT Chemical Type: 5 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: PHARMACIA AND UPJOHN CO Active Ingredient(s): ALPROSTADIL OTC/RX Status: RX Indication(s): Provides for an aqueous formulation for...
http://www.fda.gov/cder/da/ddpa92.wpd 20 005 CARDENE SR SYNTEX NICARDIPINE HYDROCHLORIDE 01 23 92 (CAPSULE, PALO ALTO, CA 30MG EXTENDED RELEASE) 94304 45MG 60MG (CALCIUM ION INFLUX INHIBITOR) [HYPERTENSION] 73 243* LOPERAMIDE HCL PERRIGO LOPERAMIDE HYDROCHLORIDE 01 21 92 (SOLUTION) ALLEGAN, MI 1MG/5ML 49010 (ANTIDIARRHEAL) (OTC) 81 264 BENZTROPINE MESYLATE MUTUAL PHARM BENZTROPINE MESYLATE 01 23 92 (TABLET) PHILADELPHIA,...
Common Cold: Viral Infections: Merck Manual Home Edition Nonprescription Cold Remedies Type Drug Side Effects Analgesics/Antipyretics (relieve aches and pains, reduce fever) - Acetaminophen Minimal - Aspirin Reye's syndrome possible in children with influenza, stomach irritation - Nonsteroidal anti- inflammatory drugs such as ibuprofen and naproxen Stomach irritation Antihistamines (open nasal passages, help relieve sneezing) -...
Introduction: Allergic Reactions: Merck Manual Home Edition Section Immune Disorders Subject Allergic Reactions Introduction Allergic reactions (hypersensitivity reactions) are inappropriate immune responses to a normally harmless substance.
Index: CL: Merck Manual Home Edition Search Recent Searches Index Sections A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Accidents and Injuries Blood Disorders Bone, Joint, and Muscle Disorders Brain, Spinal Cord, and Nerve Disorders Cancer Children's Health Issues Digestive Disorders Disorders of Nutrition and Metabolism Drugs Ear, Nose, and Throat Disorders Eye Disorders Fundamentals Heart and Blood Vessel...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, TACARYL to ZYPREXA Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS TACARYL to ZYPREXA Trade Name Generic TACARYL Methdilazine TACE Chlorotrianisene TAGAMET Cimetidine TALWIN *Pentazocine TAMBOCOR Flecainide TAMIFLU Oseltamivir TAPAZOLE Methimazole TASMAR Tolcapone TAVIST Clemastine TAXOL Paclitaxel TAZICEF Ceftazidime TAZIDIME Ceftazidime TEGISON Etretinate...
