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http://www.fda.gov/cder/orange/appendix_a.txt
400, ERYTHROMYCIN ETHYLSUCCINATE E.E.S., ERYTHROMYCIN ETHYLSUCCINATE EC-NAPROSYN, NAPROXEN ECONAZOLE NITRATE, ECONAZOLE NITRATE ECONOCHLOR, CHLORAMPHENICOL ECONOPRED PLUS, PREDNISOLONE ACETATE ECONOPRED, PREDNISOLONE ACETATE EDECRIN, ETHACRYNATE SODIUM EDECRIN, ETHACRYNIC ACID EDETATE DISODIUM, EDETATE DISODIUM EDEX, ALPROSTADIL EDROPHONIUM CHLORIDE PRESERVATIVE FREE, EDROPHONIUM...
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Prescription and OTC Drug Product List 1/1999
Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 1: January 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE BENDROFLUMETHIAZIDE; NADOLOL CAPSULE; ORAL TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN CORZIDE - ADD - AA MALLINCKRODT 500MG;5MG N88956 001 - ADD -...
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FDA Drug Approvals List- January 1998
Dosage Form: INJECTABLE Applicant: WYETH AYERST LABORATORIES INC Active Ingredient(s): GONADOTROPIN, CHORIONIC OTC/RX Status: RX Application #: 020729 Labeling Supplement#: 002 To Original New Drug Application Approval Date: 21-JAN-98 Trade Name: UNIRETIC Dosage Form: TABLET Applicant: SCHWARZ PHARMA INC Active Ingredient(s): HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE OTC/RX...
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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...
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Liposculpture and Liposuction Information - Obesity & Weight Loss
Contact Us News Home Home Cosmetic Surgeons Articles Web Resources Image Gallery Search Contact Us Main Menu Home Cosmetic Surgeons Articles Web Resources Image Gallery Search Contact Us Obesity & Weight Loss The definition of obesity varies depending on what one reads, but in general, it is a chronic condition defined by an excess amount body fat.
Medications associated with...
author: Administrator
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Phentermine for obesity - [Medication] - Quest Diagnostics Patient Health Library
Phentermine for obesity Examples Brand Name Chemical Name Adipex-P, Fastin, Ionamin, Oby-Trim phentermine Fen-phen is a combination of the medications fenfluramine and phentermine that is no longer available.
Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Phentermine for obesity - ...
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Specificity Table TOX.xls
Tested (ng/ ml) Enteramine metabolite Serotonin metab.( Hydroxy (5) indole- 3- acetic acid) Serotonin metabolite 100,000 Ephedrine Ephedrine, d- Adrenergic 10,000,000 Ephedrine Ephedrine, l- Bronchodilator 10,000,000 MeAMP 400,000 Ephedrine metabolite Ephedrine, d- metab.( Norephedrine, d-) Ephedrine, d- metabolite 100,000 Epinine Deoxyepinephrine Vasoconstrictor 100,000 Epsom salts...
author: Biosite Incorporated
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Specificity Table TOX.xls page 11
author: Biosite Incorporated
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Phen/Fen & Valvular Heart Disease
-PHEN/FEN- AND VALVULAR HEART DISEASE July 8, 1997 QUESTIONS AND ANSWERS - 1
Phentermine (-phen-) and fenfluramine (-fen-) are prescription medications approved by the FDA as single medicines for short-term (a few weeks) use as appetite suppressants in the management of obesity
Some physicians have prescribed them recently to be used in combination with each other and to...
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1996 and Older - New Drug Application (NDA)
New Drug Approval Packages These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information Office
20195/S-002 5/20/96 8/2/99 Fragmin/dalteparin sodium Injection [1.5 MB] Pharmacia and Upjohn 020287/S005 9/24/1996 2/4/1998 Heptolite, Kit for the Preparation of Technetium Tc 99m Disofenin Merck 18467/ S-13 & S-14 12/29/1993 8/5...
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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
15258 23-Jan-01 ISOCHEM SA "EPAL-NCA AS MFG IN VERT-LE-PETIT, FRANCE" 15259 22-Jan-01 SANOFI CHIMIE "FONDAPARINUX SODIUM AS MFG IN SISTERON (CEDEX) AND NOTRE DAME DE BONDEVILLE, FRANCE" 15261 24-Jan-01 TEVA GROUP "AZITHROMYCIN AS MANUFACTURED IN BE'ER SHEVA AND PETACH TIQVA, ISRAEL" 15262 05-Feb-01 DIOSYNTH BV "RECOMBINANT HUMAN INSULIN AS MFG IN THE NETHERLANDS, FRANCE, AND ISRAEL."...
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http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls
URSODEOXYCHOLIC ACID MEDIMPEX INC ALPHA METHYLDOPA USP XIX BULK AS MFG BY EGIS PHARMACEUT WORKS BUDAPEST ACRAF TRAZODONE HCL ROCHE COLORADO CORPORATION BUTOCONAZOLE NITRATE GEDEON RICHTER LTD NORETHISTERONE DINAMITE DIPHARMA SPA FUROSEMIDE USP SCHERING AG ESTRADIOL-VALERATE SCHERING AG TESTOSTERONE ENANTHATE PROQUINA SA PIPERAZINE ESTRONE SULFATE MERCK AG METHYL GLUCAMINE (PRODUCT ...
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Prescription and Over-the-Counter Drug Product List: 10/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> AA VINTAGE PHARMS 500MG/15ML;7.5MG/15ML N40520 001 OCT 30, 2003 OCT NEWA TABLET; ORAL ANEXSIA >D> AA MALLINCKRODT 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA >A> AA 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA ALBUTEROL SULFATE TABLET...
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ANDA Approvals - October 2003
- FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Approvals - October 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 40-416 WARFARIN SODIUM TABLETS, USP 1 MG, 2 MG, 2.5 MG, 3 MG 4 MG, 5 MG, 6 MG, 7.5 MG, AND 10 MG - UPSHER-SMITH LABORATORIES, INC
10/7/2003- 5 40-512 PYRIDOSTIGMINE BROMIDE TABLETS, USP 60 MG - BARR...
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Prescription and Over-the-Counter Drug Product List: 5/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, APAP, AND CAFFEINE -A- AB AXIOM PHARM 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN -D- AB HALSEY 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 500MG;7.5MG...
author: AUTHOR
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ANDA Approvals January 2003
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - January 2003 - ANDA Number- Generic Drug Name Applicant Approval Date 1 40-474 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/650 MG ABLE LABORATORIES, INC
1/6/03 3 76-266 DOXAPRAM HYDROCHLORIDE INJECTION, USP 20 MG/ML (400 MG/20 ML) MULTIPLE- DOSE...
author: OGD
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Prescription and Over-the-Counter Drug Product List: 1/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE -A- SOLUTION; ORAL -A- ACETAMINOPHEN AND BUTALBITAL AND CAFFEINE -A- + MIKART 325MG/15ML;50MG/15ML;40MG/15ML N40387 001 JAN 31, 2003 JAN NEWA ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL ACETAMINOPHEN AND CODEINE PHOSPAHTE -A- AA ANDRX PHARMS 300MG;15MG N40443 001 JAN 22, 2003 JAN NEWA -A- AA...
author: AUTHOR
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ANDA Approvals March 2003
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - March 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 40-455 NOREPINEPHRINE BITARTRATE INJECTION, USP 1 MG (BASE)/ML, PACKAGED IN 4 MG (BASE)/4 ML SINGLE-DOSE VIALS GENSIA SICOR PHARMACEUTICALS, INC
3/5/2003- 4 40-497 PHENTERMINE HYDROCHLORIDE...
author: OGD
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Prescription and Over-the-Counter Drug Product List: 3/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL FIORICET W/ CODEINE -D- AB + NOVARTIS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN -A- AB + WATSON PHARMS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL CODRIX -A- + ANDRX PHARMS 500MG;30MG N40441 001...
author: AUTHOR
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1997 Abbreviated New Drug Applications (Generic Drugs)
074946 11/19/1997 3/30/1998 Adriamycin PFS (Doxorubicin Hydrochloride) Injection ,- Adria Laboratories 63165/S3, S5, S6 7/9/1993 8/8/2002 Albuterol Inhalation Aerolsol, 90 mcg/Actuation
64136 9/30/96 4/13/99 Clomipramine Hydrochloride [2 MB] Taro Pharmaceuticals 074694 12/13/1996 12/3/1997 Clomipramine Hydrochloride Capsules, 25, 50, & 75 mg
74-648 3/18/97 4/8...
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FDA Drug Approvals List August 2001
Active Ingredient(s): PROPRANOLOL HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Application #: 040427 Tentative Approval Date: 30-AUG-01 Trade Name: PHENTERMINE HYDROCHLORIDE Dosage Form: CAPSULE Applicant:ABLE LABORATORIES, INC
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Application #: 040402...
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FDA Drug Approvals List January 2002
- Drug Approvals for January 2002 Definitions and Notes Original New Drug Applications Efficacy Supplemental New Drug Applications Application #: 020837 Efficacy Supplement #: 006 Type: SE5 to Original New Drug Application Approval Date: 30-JAN-02 Trade Name: XOPENEX Dosage Form: SOLUTION Applicant: SEPRACOR, INC Active Ingredient(s): LEVALBUTEROL HYDROCHLORIDE OTC/RX Status:...
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Prescription and OTC Drug Product List 8/2001
ACTHAR GEL -D- BC + AVENTIS 40 UNITS/ML N08372 006 FEB 06, 1956 AUG CAHN -D- BC + 80 UNITS/ML N08372 008 FEB 06, 1956 AUG CAHN -A- BC + QUESTCOR PHARMS 40 UNITS/ML N08372 006 FEB 06, 1956 AUG CAHN -A- BC + 80 UNITS/ML N08372 008 FEB 06, 1956 AUG CAHN DELAVIRDINE MESYLATE TABLET; ORAL RESCRIPTOR -D- + AGOURON 100MG N20705 001 APR 04, 1997 AUG CRLD -A- 100MG N20705 001 APR 04, 1997 AUG...
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Prescription and OTC Drug Product List 7/2001
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE -A- AB ABLE 325MG;50MG;40MG N40390 001 JUL 23, 2001 JUL NEWA -A- AB 500MG;50MG;40MG N40394 001 JUL 23, 2001 JUL NEWA ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA + WATSON LABS 325MG;7.5MG...
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Prescription and OTC Drug Product List 1/2002
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA KV PHARM 500MG/15ML;7.5MG/15ML N40366 001 JAN 23, 2002 JAN NEWA AMPHOTERICIN B INJECTABLE, LI COMPLEX; INJECTION ABELCET -A- + ELAN PHARMS 5MG/ML N50724 001 NOV 20, 1995 JAN CAHN -D- + LIPOSOME 5MG/ML N50724 001 NOV 20, 1995 JAN...
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