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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,...
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19726S018_Zoladex.htm
Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Zoladex (Goserelin Acetate Implant) Company:--Zeneca Pharmaceuticals, Inc
Application No.:--19-726/S-018 Approval Date:-6/27/1997 - Approval Letter(s) - Medical Review(s) - Chemistry Review(s) - Environmental Assessment - Pharmacology Review(s) Statistical Review(s...
author: Paul Stauffer
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19726-s024_Zoladax.htm
Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Zoladex (Goserelin Acetate) Depot 3.6mg & 10.8mg Company:- Zeneca Pharmaceuticals, Inc
Application No.:- 19-726/S24 & 20-578/S3 Approval Date:-7/28/1998 - Approval Letter(s) - Medical Review(s) - Clinical Pharmacology Biopharmaceutics Review(s) - Administrative...
author: Paul Stauffer
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1997 New Drug Application (NDA)
74905 8/26/1997 9/28/01 Follistim Organon 020582 09/29/1997 8/11/2003 Fortovase/Saquinavir Approval Letter [181 KB] Medical Review(s) Part 1 [2.3 MB], & Part 2 [3.5 MB] Chemistry Review(s), Environmental Assessment and/or FONSI, Pharmacology Review(s) [2.5 MB] Statistical Review(s), Clinical Pharmacology & Biopharmaceutics Review(s), Administrative Document(s) [1.9 MB] Hoffman...
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rld_labeling_approved_apr_1999
Firm Date VEPESID Etoposide Capsule Etoposide Injection 19-557 18-768 S-023 S-041 Bristol 2-Apr-1999 NOLVADEX Tamoxifen Citrate Tablet 17-970 S-043 Zeneca Pharms 2-Apr-1999 ZOLADEX 3-MONTH Goserelin Acetate Implant 20-578 S-001 Zeneca Pharms 14-Apr-1999 CHILDREN'S MOTRIN ORAL SUSPENSION 40 MG/ML Ibuprofen Oral Suspension (Concentrated - Drops) 20-603 S-003 Mc Neil...
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FDA Drug Approvals List February 2002
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Antibiotic Application#065022 Approval Date: 27-FEB-02 Trade Name: BACITRACIN ZINC AND POLYMYXIN B SULFATE Dosage Form: OINTMENT Applicant: ALTANA INC Active Ingredient(s): BACITRACIN ZINC; POLYMYXIN B SULFATE OTC/RX Status: RX Original Abbreviated Application# 075874 Approval Date: 26-FEB-02 Trade...
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RLD_LABELING_APPROVED_NOV_1999
Firm Date AMINOHIPPURATE Na Na Aminohippurate 5-619 S-015 Merck 2-Nov-1999 FLOLAN Epoprostenol Na Injection 20-444 S-004 Glaxo Wellcome 2-Nov-1999 DEXEDRINE Dextroamphetamine SO4 ER Capsules 17-078 S-034 SmithKline Beecham 3-Nov-1999 ZOLADEX Goserelin Acetate Implant 20-578 S-009 Zeneca 3-Nov-1999 ZOLADEX Goserelin Acetate Implant 3.6 Mg 19-726 S...
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pi.pdf page 1
author: gracej
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pi.pdf
ee CONTRAINDICATION ZOLADEX 10 8 mg is not indicated in women as the data are insufficient to support reliable suppression of serum estradiol tudies in both rats and rabbits at doses of 2, 10, 20, and 50 µg/ kg/ day and 20, 250, and 1, 000 µg/ kg/ day, respectively ( about 1/ 10 to 3 times and 2 to 100 times the daily maximum recommended human dose, respectively, on a...
author: gracej
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pi.pdf page 1
author: gracej
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Prescription Drug Product List 1/96
PRESCRIPTION DRUG PRODUCT LIST 16TH EDITION RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 1 / JAN'96 ACETAMINOPHEN; CODEINE PHOSPHATE CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE TABLET; ORAL - ADD - ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION; INTRAPERITONEAL - ADD - AA MIKART 300MG;60MG N89244 001 - ADD - DELFLEX W/ DEXTROSE 4.25% IN...
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FDA Drug Approvals List- April 1998
Application #: 020555 Efficacy Supplement#: 003 Type: SE1 to Original New Drug Application Approval Date: 01-APR-98 Trade Name: AXID AR Dosage Form: TABLET Applicant: WHITEHALL ROBINS HEALTHCARE Active Ingredient(s): NIZATIDINE OTC/RX Status: OTC Efficacy Claim: Provides for treatment of episodic heartburn, acid indigestion and sour stomach Application #: 020393 Efficacy Supplement#:...
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February Drug Approvals
Drug Approvals for February 1997 Definitions and Notes February 1997 Original New Drug Applications Original Application #: 020723 Approval Date: 27-FEB-97 Trade Name: ALDARA Chemical Type: 1 Therapeutic Potential: S Dosage Form: CREAM Applicant: 3M PHARMACEUTICALS INC Active Ingredient(s): IMIQUIMOD OTC/RX Status: RX Indication(s): Treatment of external genital and perianal warts...
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FDA Drug Approvals List November 1999
Approvable Original New Drug Applications Original Application #: 020125 Approvable Date: 30-NOV-99 Trade Name: ACCURETIC Dosage Form: TABLET Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO Active Ingredient(s): QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE OTC/RX Status: RX Original Abbreviated Application #: 075366 Tentative Approval Date: 02-NOV-99 Trade Name:...
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FDA Drug Approvals List- July 1998
Drug Approvals for July 1998 Definitions and Notes July 1998 Original New Drug Applications Original Application #: 020822 Approval Date: 17-JUL-98 Trade Name: CELEXA Chemical Type: 1 Therapeutic Potential: S Dosage Form: TABLET Applicant: FOREST LABORATORIES INC Active Ingredient(s): CITALOPRAM HYDROBROMIDE OTC/RX Status: RX Indication(s): TREATMENT OF DEPRESSION Original...
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DDPA December 1995
74-589 MINOXIDIL LEMMON MINOXIDIL 15-DEC-95 (SOLUTION) SELLERSVILLE, PA 2% 18960 (HAIR GROWTH STIMULATOR) 74-643 MINOXIDIL BAUSCH AND LOMB MINOXIDIL 22-DEC-95 (SOLUTION) TAMPA, FL 2% 33637 (HAIR GROWTH STIMULATOR) 74-418 CAPTOPRIL ENDO CAPTOPRIL 28-DEC-95 (TABLET) GARDEN CITY, NY 12.5MG 11530 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO...
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DDPA August 1995
20-401 TIAZAC BIOVAIL DILTIAZEM HYDROCHLORIDE 01-AUG-95 (CAPSULE, SCARBOROUGH, ONTARIO 120MG EXTENDED RELEASE) CANADA 180MG 240MG 300MG 360MG (CALCIUM ION INFLUX INHIBITOR) [HYPERTENSION] 20-465 AZULFIDINE EN-TABS KABI PHARMACIA SULFASALAZINE 02-AUG-95 (TABLET, COLUMBUS, OH 500MG DELAYED RELEASE) 43216 (ANTI-INFLAMMATORY) [TREATMENT OF RHEUMATOID ARTHRITIS] 50-673 CECLOR CD ELI LILLY...
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DDPA January 1996
Drug and Device Product Approvals for January 1996 ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 19-963 RENOVA RW JOHNSON TRETINOIN 29-DEC-95 (CREAM) RARITAN, NJ 0.05% (3 S) 08869 (RETINOID) 20-353 NAPRELAN ELAN NAPROXEN SODIUM 05-JAN-96 (TABLET, GAINESVILLE, GA EQ 375MG BASE (3 S) EXTENDED RELEASE) 30504 EQ 500MG BASE EQ 750MG BASE (NONSTEROIDAL ANTI-INFLAMMATORY) 20...
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Drug Approvals for June 1997
Drug Approvals for June 1997 Definitions and Notes June 1997 Original New Drug Applications Original Application #: 020729 Approval Date: 27-JUN-97 Trade Name: UNIRETIC Chemical Type: 4 Therapeutic Potential: S Dosage Form: TABLET Applicant: SCHWARZ PHARMA INC Active Ingredient(s): HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE OTC/RX Status: RX Indication(s): Treatment of patients...
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http://www.fda.gov/cder/da/ddpa93.wpd
DEPARTMENT OF HEALTH AND HUMAN SERVICES, PUBLIC HEALTH SERVICE NDA NUMBER APPROVAL DATE (CLASSIFICATION)TRADE NAME (DOSAGE FORM)APPLICANTACTIVE INGREDIENT(S) STRENGTH(S) CLASSIFICATION(S) ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 19 726 ZOLADEX IMPERIAL CHEM GOSERELIN ACETATE 02 02 93 (IMPLANT) CHESHIRE, ENGLAND EQ 3.6MG BASE (SUPPL) (NEW INDICATION...
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Generic Names of Some Trade Name Drugs, THE MERCK MANUAL OF HEALTH & AGING
Committed to Providing Medical Information Table of Contents Index Enlarge Text Reset Text Shrink Text -- Buy the Book Learn about participating in clinical trials at this government website: www.clinicaltrials.gov - APPENDIX I - Drug Names: Generic and Trade TOPICS - Introduction -~ Some Trade Names of Generic Drugs -~ Generic Names of Some Trade Name Drugs - Generic Names of Some...
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Some Trade Names of Generic Drugs, THE MERCK MANUAL OF HEALTH & AGING
Committed to Providing Medical Information Table of Contents Index Enlarge Text Reset Text Shrink Text -- Buy the Book Learn about participating in clinical trials at this government website: www.clinicaltrials.gov - APPENDIX I - Drug Names: Generic and Trade TOPICS - Introduction -~ Some Trade Names of Generic Drugs-~ Generic Names of Some Trade Name Drugs - Some Trade Names of...
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Cancer: Prostate Disorders: 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...
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Premenstrual Syndrome: Menstrual Disorders and Abnormal Vaginal Bleeding: 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...
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Dysmenorrhea: Menstrual Disorders and Abnormal Vaginal Bleeding: 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...
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