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http://www.fda.gov/cder/orange/appendix_a.txt
RTU IN PLASTIC CONTAINER, METRONIDAZOLE FLAGYL I.V., METRONIDAZOLE HYDROCHLORIDE FLAGYL, METRONIDAZOLE FLAREX, FLUOROMETHOLONE ACETATE FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE FLAVOXATE HCL, FLAVOXATE HYDROCHLORIDE FLAXEDIL, GALLAMINE TRIETHIODIDE FLECAINIDE ACETATE, FLECAINIDE ACETATE FLEXERIL, CYCLOBENZAPRINE HYDROCHLORIDE FLEXICORT, HYDROCORTISONE FLOLAN, EPOPROSTENOL SODIUM...
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First-Time Generics - December 2002
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - December 2002 - Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 AMANTADINE HYDROCHLORIDE TABLETS 100 MG UPSHER-SMITH LABORATORIES, INC
SYMMETREL TABLETS 12/16/02 2 DILTIAZEM HYDROCHLORIDE FOR INJECTION 100 MG ADD-VANTAGE VIALS ABBOTT...
author: OGD
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Prescription and OTC Drug Product List 12/2002
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACARBOSE TABLET; ORAL PRECOSE -D- BAYER 25MG N20482 004 MAY 29, 1997 DEC CAHN -D- 50MG N20482 001 SEP 06, 1995 DEC CAHN -D- + 100MG N20482 002 SEP 06, 1995 DEC CAHN -A- BAYER PHARMS 25MG N20482 004 MAY 29, 1997 DEC CAHN -A- 50MG N20482 001 SEP 06, 1995 DEC CAHN -A- + 100MG N20482 002 SEP 06, 1995 DEC CAHN ACYCLOVIR -A- CREAM;...
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material_safety_data_sheet_letter_new_.doc
ALLERGAN 2525 Dupont Drive, P.
In addition, we believe that all safety concerns regarding our products are described on the package inserts that accompany them.
Hutton Manager, Health & Safety Product List Not Requiring MSDS ACULAR® (Ketorolac Tromethamine Ophthalmic Solution) 0.5% FML® (Fluorometholone Ophthalmic Suspension) 0.1% ACULAR LS™ (Ketorolac...
author: hutton_ronald
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material_safety_data_sheet_letter_new_.doc page 2
author: hutton_ronald
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Drug Approvals - D
Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted DMSA (Kit for the preparation of Tc99m Succimer for Injection), Rx Amersham Health NDA 17-944/S-018 11/24/03 11/25/03 - - Dacarbazine for Injection USP, 200 mg/vial, Rx Faulding Pharmaceutical Co
ANDA 40-436 1/29/02 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine...
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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
EPHINEPHRINE BITARTRATE 5782 08-Apr-85 XTTRIUM LABS INC CHLORHEXIDINE GLUCONATE 20% SOLUTION 5787 29-Mar-85 PHARMACIA AND UPJOHN INC DIFLORASONE DIACETATE 5791 27-Mar-85 BOEHRINGER INGELHEIM PHARMA GMBH & CO KG
"TERAZOSIN HCL-FORM 1, MANUFACTURED IN VARESE, ITALY" 12585 09-Jul-97 ACS DOBFAR SPA "SODIUM BICARBONATE, STERILE, MANUFACTURED IN MILANO, ITALY" 12586 09-Jul...
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http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls
DIAZEPAM AVENTIS PHARMA SA CHLORPROMAZINE HYDROCHLORIDE PHARMACIA AND UPJOHN INC CYTARABINE AS MANUFACTURED IN KALAMAZOO MI PHARMACIA AND UPJOHN INC MEDRYSONE PHARMACIA AND UPJOHN INC FLUOROMETHOLONE MICRONIZED AVENTIS PHARMA SA CROMOLYN SODIUM AND CROMOLYN SODIUM/LACTOSE BLEND ADAMHA NIMH DELTA-9-TRANS-TETRAHYDROCANNABINOL-DELTA-9-TRANS-TETRAHYDROCANNABINOL SSL INTERNATIONAL...
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ANDA Approvals December 2002
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - December 2002 - ANDA- Number Generic Drug Name Applicant Approval Date 1 65-116 BACITRACIN FOR INJECTION, USP 50,000 UNITS/VIAL AMERICAN PHARMACEUTICAL PARTNERS, INC
12/16/02 6 76-186 AMANTADINE HYDROCHLORIDE TABLETS 100 MG UPSHER-SMITH LABORATORIES, INC
12/16/02 7 76...
author: OGD
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75-374_Diflorasone Diacetate Ointment
Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Diflorasone Diacetate Ointment Company:--Altana Inc
Application No.:--75-374 Approval Date:-4/27/1999 - Approval Letter(s) - Printed Labeling - Chemistry Review(s) - Bioequivalence Review(s) Administrative Document(s) - Correspondence - - Back to Drug Approval Page Some...
author: Paul Stauffer
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FDA Drug Approvals List April 2000
Approvable Original New Drug Applications Original Abbreviated New Drug Applications Original Abbreviated Application # 074657 Approval Date: 28-APR-00 Trade Name: TERAZOSIN HCL Dosage Form: TABLET Applicant: INVAMED INC Active Ingredient(s): TERAZOSIN HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Antibiotic Application# 065041 Approval Date: 28-APR-00 Trade Name: DOXYCYCLINE...
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Prescription and OTC Drug Product List 6/1999
Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 6: June 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE AMINO ACIDS TABLET; ORAL INJECTABLE; INJECTION PERCOCET NOVAMINE 8.5% - ADD - AA ENDO PHARMS 325MG;5MG N40330 002 - DLT - @ PHARMACIA AND UPJOHN 8.5% N17957 002...
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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...
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FDA Drug Approvals List- May 1999
Efficacy Supplemental New Drug Applications Application #: 020584 Efficacy Supplement#: 003 Type: SE2 to Original New Drug Application Approval Date: 27-MAY-99 Trade Name: LODINE XL Dosage Form: TABLET, EXTENDED RELEASE Applicant: WYETH AYERST LABORATORIES INC Active Ingredient(s): ETODOLAC OTC/RX Status: RX Efficacy Claim: For the management of the signs and symptoms of...
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FDA Drug Approvals List- April 1999
Original Application #: 050760 Approval Date: 15-APR-99 Trade Name: AMOXIL Chemical Type: 3 Therapeutic Potential: S Dosage Form: SUSPENSION Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS Active Ingredient(s): AMOXICILLIN OTC/RX Status: RX Indication(s):For the use of Amoxil for oral suspension 200mg/5mL and 400mg/5mL in divided doses q12h Original Application #: 020924 Approval Date:...
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http://www.fda.gov/cder/foi/appletter/2000/75508ltr.pdf
ANDA 75- 508 April 24, 2000 Taro Pharmaceuticals U
Attention: Lorraine Sachs 5 Skyline Drive Hawthorne, NY 10532 Dear Madam: This is in reference to your abbreviated new drug application dated November 19, 1998, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Diflorasone Diacetate Cream USP, 0.05%
We have completed the...
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http://www.fda.gov/cder/foi/appletter/2000/75508ltr.pdf page 1
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75374.AP.DOC
ANDA 75- 374 April 27, 1999 Altana Inc
Attention: Virginia Carman 60 Baylis Road Melville, NY 11747 Dear Madam: This is in reference to your abbreviated new drug application dated May 1, 1998, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act, for Diflorasone Diacetate Ointment USP, 0.05%
Reference is also made to your amendments...
author: Unknown
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75374.AP.DOC page 1
author: Unknown
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