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...
Prescription and OTC Drug Product List 4/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL ACETAMINOPHEN, BUTALBITAL, CAFFEINE, AND CODEINE PHOSPHATE -A- AB VINTAGE PHARMS 325MG;50MG;40MG;30MG N75929 001 APR 22, 2002 APR NEWA ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE;...
Prescription and OTC Drug Product List 12/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 12: December 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - ADD - ABACAVIR SULFATE ALBUTEROL SULFATE - ADD - SOLUTION; ORAL SOLUTION; INHALATION - ADD - ZIAGEN ALBUTEROL SULFATE - ADD - + GLAXO WELLCOME EQ 20MG BASE/ML N20978 001 - ADD - @ COPLEY PHARM...
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...
FDA Drug Approvals List- December 1998 Drug Approvals for December 1998 Definitions and Notes December 1998 Original New Drug Applications Original Application #: 020998 Approval Date: 31-DEC-98 Trade Name: CELEBREX Chemical Type: 1 Therapeutic Potential: P Dosage Form: CAPSULE Applicant: GD SEARLE AND CO Active Ingredient(s): CELECOXIB OTC/RX Status: RX Indication(s):For the signs and symptoms of osteoarthritis and...
DDPA December 1995 20-545 PROCANBID PARKE DAVIS PROCAINAMIDE HYDROCHLORIDE 14-DEC-95 (TABLET, ANN ARBOR, MI 500MG EXTENDED RELEASE) 48106 1000MG (ANTIARRHYTHMIC) 20-518 RETROVIR GLAXO WELLCOME ZIDOVUDINE 19-DEC-95 (TABLET) RES TRIANGLE PK, NC 300MG 27709 (ANTIVIRAL) 20-535 BROMFENAC SODIUM WYETH AYERST BROMFENAC SODIUM 28-DEC-95 (CAPSULE) RADNOR, PA EQ 25MG BASE 19087 EQ 50MG BASE (NONSTEROIDAL ANTI...
Drug and Device Approvals March 1995 20-386 COZAAR MERCK LOSARTAN POTASSIUM 02-MAR-95 (TABLET) WEST POINT, PA 25MG 19486 50MG (ANGIOTENSIN II RECEPTOR ANTAGONIST) [HYPERTENSION] 20-169 NILANDRON BESSELAAR ASSOC NILUTAMIDE 07-MAR-95 (TABLET) PRINCETON, NJ 50MG 08540 (ANTIANDROGEN) [METASTATIC PROSTATE CANCER] 20-173 TRAVASOL 5.5% BAXTER AMINO ACIDS 09-MAR-95 W/ELECTROLYTES ROUND LAKE, IL 5.5% [SULFITE-FREE] 60073...
1999 Warning Letters and Untitled Letters to Pharmaceutical Companies Food and Drug Administration • Center for Drug Evaluation and Research Compliance Activities Search Warning Letters and Untitled Letters to Pharmaceutical Companies 1999 These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office
Alefacept (Amevive) Clinical Review page 62
author: CBER FDA
subject: dob062703
Forum - Read Topic Dupuytren's Disease Patient Discussion Forum - Topic: "Fasciotomy vs.
Topical corticosteroids for atopic dermatitis - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Topical corticosteroids for atopic dermatitis - [Medication] - Quest Diagnostics Patient Health Library Topical corticosteroids for atopic dermatitis - [Medication] - Quest Diagnostics Patient Health Library anti-itch medications, antipruritic medications,...
Database C C - investigational drugs, therapies and vaccines # - 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 From this page you may order documents with information covering investigational products.
Database O O - investigational drugs, therapies and vaccines # - 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 From this page you may order documents with information covering investigational products To purchase documents on-line click on- -link attached to selected document!- The fee is $15 per document Documents are delivered by e-mail...
NDA Approvals for Calendar Year 2003 NDA APPROVALS FOR CALENDAR YEAR 2003 Updated through December 31, 2003 NDA NUMBER DRUG NAME GENERIC NAME APPLICANT/ SPONSOR CHEMICAL TYPE THERAPEUTIC CLASS APPROVAL DATE - 21434 Xanax XR Alprazolam Pharmacia and Upjohn FR 3 S 17-Jan-03 21305 Sodium Iodide I-131 Sodium Iodide I-131 DraxImage 3,5 S 24-Jan-03 20414 Pyridostigmine Bromide Pyridostigmine Bromide US Army 3 P 05-Feb-03...
author: Susan Daugherty
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt LISINOPRIL CRUDE AS MFG IN COURBEVOIE AND HAM FRANCE 14537 19-Nov-99 FUJISAWA PHARMACEUTICAL CO LTD FK8453 DRUG SUBSTANCE AS MFG IN HYOGO AND OSAKA JAPAN 14538 09-Nov-99 SICOR DE MEXICO SA DE CV AMCINONIDE AS MFG IN LERMA MEXICO 14539 18-Nov-99 "UQUIFA ITALIA, S.P.A." CLINDAMYCIN HYDROCHLORIDE USP AS MFG IN MILAN ITALY 14540 18-Nov-99 DIOSYNTH BV TESTOSTERONE UNDECANOATE AS MFG IN...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls Arthur Shaw CDER User $ ($) $ ($) $ ($) $ ($) $ $ () $ - () - $ $ () $ - () - -- -- $ ($) $ ($) $ ($) $ ($) / / // -- - - : : :: : () () () () () - $ $ () $ - () - $ $ () $ - : :: : 4Q2003 TYPE2ACTIVEEXCEL DMF # SUBMIT DATE HOLDER SUBJECT CENTRAL SOYA SOYBEAN STEROL PRODUCTS INTERNATIONAL SPECIALTY PRODUCTS POLYVINYL PYRROLIDONE-IODINE 10 MALLINCKRODT CHEMICAL INC PARZONE BITARTRATE ...
Prescription and Over-the-Counter Drug Product List: 7/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE TABLET; ORAL PROPOXYPHENE HCL AND ACETAMINOPHEN >A> AA VINTAGE PHARMS 650MG;65MG N40507 001 JUL 30, 2003 JUL NEWA ACYCLOVIR TABLET; ORAL ACYCLOVIR >D> AB CLONMEL HLTHCARE 400MG N74834 001 APR 24, 1997 JUL DISC >A> @ 400MG N74834 001 APR 24, 1997 JUL DISC >D> AB 800MG N74834 002 APR 24,...
author: AUTHOR
ANDAs Approvals - May 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office Of Generic Drugs ANDAs Approvals May 2000 - 1
author: USERNAME
CDER Template - Replace Title Here Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - April 2002 - ANDA Number- Drug Name Applicant Approval Date 1 75-521 BUSPIRONE HYDROCHLORIDE TABLETS, USP 5 MG, 10 MG, AND 15 MG TORPHARM 4/5/02 2 75-863 DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL TABLETS 0.15 MG/0.02 MG AND 0.01 MG RESPECTIVELY (28-DAY CYCLE) BARR...
author: USERNAME
75-224_Clobetasol Propionate Topical Solution Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Clobetasol Propionate Topical Solution Company:--Taro Pharmaceticals USA, Inc
author: Paul Stauffer
Clobetasol Propionate Cream USP .05% Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Clobetasol Propionate Cream USP.05% Company:- Altana Inc
author: USERNAME
Alefacept (Amevive) Clinical Review page 25
author: CBER FDA
subject: dob062703
1997 Abbreviated New Drug Applications (Generic Drugs) Generic Drug Approval Packages These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information Office
ANDA Approvals February 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Approvals February 2001 ANDA NUMBER DRUG- NAME APPLICANT APPROVAL DATE 1 65-061 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP 150 MG (BASE)------- 300 MG (BASE) RANBAXY LABORATORIES LIMITED 2/2/01 2 75-738 PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP 100 MG/650 MG MALLINCKRODT INC
author: USERNAME
FDA Drug Approvals List August 2001 Active Ingredient(s): PREDNISONE OTC/RX Status: RX Original Abbreviated Application # 075733 Approval Date: 22-AUG-01 Trade Name: CLOBETASOL PROPIONATE Dosage Form: EMULSION, CREAM Applicant: STIEFEL LABORATORIES INC Active Ingredient(s): CLOBETASOL PROPIONATE OTC/RX Status: RX Original Abbreviated Application # 074911 Approval Date: 22-AUG-01 Trade Name:...
