Forum - Read Topic
Dupuytren's Disease Patient Discussion Forum - Topic: "Fasciotomy vs. I was in error posting that it was from Tom. We all have to decide what option is right for us, and for 'Dr. That's fine, but why not have said so up front? The question I didn't ask was what is the downside of having fasciotomy? She has said after looking at his hand, the first time, -Don't have...
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. Product development terminated! Approved by the FDA in September 2001 Catrix® (1496) CAV-6.1 (Candida Albicans Vaccine) (1550)...
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...
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,...
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 5/1/00 TABLETS 80 MG 120 MG 160 MG 240 MG 2 75-429 SOTALOL HYDROCHLORIDE TEVA PHARMACEUTICALS USA 5/1/00 TABLETS 80 MG 120 MG 160 MG 240 MG 4 5/2/00 ATROPINE SULFATE TABLETS, USP 2.5 MG/0.025 MG 5 5/4/00 (OTC) 75 MG 7
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 Application No.:--75-224 Approval Date:-11/16/1998 - Approval Letter(s) - Printed Labeling - Chemistry Review(s) - Bioequivalence Review(s) Administrative Document(s) Correspondence - - Back to...
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 Application No.:- 75-430 Approval Date:-5/26/1999 Approval Letter(s) - Printed Labeling - - Chemistry Review(s) -- Bioequivalence Review(s) -- Administrative Document(s) - Correspondence - - Back to Drug Approval...
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 074750 4/22/1997 2/6/1998 Acyclovir Capsules, 200 mg 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,...
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 2/2...
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:...
FDA Drug Approvals List February 2001
Approvable Original New Drug Applications - Original Abbreviated New Drug Applications Original Abbreviated Application # 075402 Approval Date: 28-FEB-01 Trade Name: METAPROTERENOL SULFATE Dosage Form: SOLUTION Applicant: NOVEX PHARMA Active Ingredient(s): METAPROTERENOL SULFATE OTC/RX Status: RX Original Abbreviated Application # 075403 Approval Date: 28-FEB-01 Trade Name:...
Prescription and OTC Drug Product List 8/2001
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST PRESCRIPTION DRUG PRODUCT LIST - 21ST EDITION ADDITIONS/DELETIONS FOR RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 8 - AUG 2001 ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL PHRENILIN WITH CAFFEINE AND CODEINE -A- AB AMARIN PHARMS 325MG;50MG;40MG;30MG N74911 001 AUG 22, 2001 AUG NEWA ACETAMINOPHEN;...
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;...
FDA Drug Approvals List February 2000
- Drug Approvals for February 2000 Definitions and Notes Original New Drug Applications Original Application #: 021015 Approval Date: 28-FEB-00 Trade Name: ANDROGEL Chemical Type: 3 Therapeutic Potential: S Dosage Form: GEL Applicant: UNIMED PHARMACEUTICALS INC Active Ingredient(s): TESTOSTERONE OTC/RX Status: RX Indication(s): For replacement therapy in males for conditions...
Efficacy Supplements Approved in Calendar Year 2002 (SE1-SE7 AND SE8s
EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2002 (SE1 -SE7)* and EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2002 (SE8)* - GENERIC NAME APPLICANT NDA NUMBER SUPP TYPE SUPP NUMBER RECEIPT DATE APPROVAL DATE PRIORITY REVIEW- TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION ANASTROZOLE ASTRAZENECA 20-541 SE1 010 5-Mar-02 5-Sep-02 Y 6.0 Provides for the use of ARIMIDEX ...
author: Darlene Norris
ranbaxy
- - - - - - You are here :- Home - Products - - Dosage Forms - INDIA DOSAGE FORMS LIST- (Updated Jan 2002) Anti-infectives G.I. & Nutritionals CVS & Diabetes CNS NSAID & related Anti-allergants ...
ANDA 75-338
ANDA 75- 338 February 9, 2001 Stiefel Laboratories, Inc Attention: Mary Jane Carr Route 145 Oak Hill, NY 12460 Dear Madam: This is in reference to your abbreviated new drug application dated February 13, 1998, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Clobetasol Propionate Cream USP, 0.05% Reference is also made to...
author: CDER User
ANDA 75-338 page 1
author: CDER User