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,...
http://www.fda.gov/cder/orange/appendix_a.txt
2, BUTABARBITAL SODIUM SARISOL, BUTABARBITAL SODIUM APPENDIX A PRODUCT NAME INDEX SATRIC, METRONIDAZOLE SCABENE, LINDANE SCANDONEST L, LEVONORDEFRIN SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE SCLEROSOL, TALC SCRUBTEAM SURGICAL SPONGEBRUSH, HEXACHLOROPHENE SEASONALE, ETHINYL ESTRADIOL SECOBARBITAL SODIUM, SECOBARBITAL SODIUM SECONAL SODIUM, SECOBARBITAL SODIUM SECREFLO, SECRETIN...
Alefacept (Amevive) Clinical Review page 25
author: CBER FDA
subject: dob062703
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
Prescription and OTC Drug Product List October 1997
Prescription and Over-the-Counter Drug Product List - 17th Edition Cumulative Supplement Number 10: Jan '97 - Oct '97 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE; ORAL OXYCODONE AND ACETAMINOPHEN TABLET;...
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...
ANDA 75-363
ANDA 75- 363 December 29, 2000 Thames Pharmacal Co., Inc Attention: Srinivasa Rao 2100 Fifth Avenue Ronkonkoma, NY 11779 Dear Sir: This is in reference to your abbreviated new drug application dated April 17, 1998, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Clobetasol Propionate Topical Solution USP, 0.05% Reference...
author: CDER User
ANDA 75-363 page 1
author: CDER User
75279.AP.DOC page 1
author: Unknown
75430.AP.DOC
ANDA 75- 430 May 26, 1999 Altana Inc Attention: Virginia Carman 60 Baylis Road Melville, New York 11747 Dear Madam: This is in reference to your abbreviated new drug application dated August 5, 1998, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act, for Clobetasol Propionate Cream USP, 0.05%, (Emollient) Reference is also made to...
author: Unknown
75430.AP.DOC page 2
author: Unknown
H: 25.PDF
ANDA 75- 325 December 24, 1998 Healthpoint, Ltd Attention: Mark Mitchell 318 McCullough San Antonio, TX 78215 Dear Sir: This is in reference to your abbreviated new drug application dated January 31, 1998, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act, for Embeline E Emollient Cream (Clobetasol Propionate Cream, [Emollient]), 0...
author: Unknown
H: 25.PDF page 1
author: Unknown
DDPA July 1995
74-477 CAPTOPRIL HALLMARK PHARMA CAPTOPRIL 31-JUL-95 (TABLET) SOMERSET, NJ 12.5MG 08873 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 17-087 ETHRANE OHMEDA ENFLURANE 05-JUL-95 (LIQUID) LIBERTY CORNER, NJ 99.9% 07938 (LABELING REVISION -- PRECAUTIONS) 17-624 FORANE OHMEDA ISOFLURANE 05-JUL-95 (LIQUID) LIBERTY CORNER, NJ 99.9%...
DDPA May 1996
Drug and Device Product Approvals for May 1996 ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 16-191 SORBITRATE ZENECA ISOSORBIDE DINITRATE 01-APR-96 (TABLET, SUBLINGUAL) WILMINGTON, DE 2.5MG (SUPPL-033) 19850 5MG (VASODILATOR) [MET CONDITIONS FOR APPROVAL PER FEDERAL REGISTER NOTICE OF AUGUST 3, 1984 (49 FR 31151)] 16-192 SORBITRATE ZENECA ISOSORBIDE DINITRATE 01-APR-96 ...
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...
Drug Approval Package: Temovate Ointment 0.05% 19323-S16
FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Drug Review Package Temovate (clobetasol propionate) Ointment, 0.05% Company:- Glaxo Wellcome Inc - Date created: August 1, 2003 CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page...
Drug Approval Package: Temovate Cream 0.05% 19322-S15
FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Drug Review Package Temovate (clobetasol propionate) Cream, 0.05% Company:- Glaxo Wellcome Inc - Date created: August 1, 2003 CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page FDA...
Alefacept (Amevive) Clinical Review page 62
author: CBER FDA
subject: dob062703
NDA-I2: NDA Approval Letter page 9
author: SUZANNE CHILDS
subject: NDA Approval Letter - FPL acceptable
NDA-I2: NDA Approval Letter page 7
author: SUZANNE CHILDS
subject: NDA Approval Letter - FPL acceptable
http://www.fda.gov/cder/foi/label/2000/21142lbl.pdf
OLUXaeFoam, 0.05% 1 (clobetasol propionate) 2 3 Rx Only 4 For Dermatologic Use Only 5 Not for Ophthalmic Use 6 7 DESCRIPTION 8 OLUX Foam contains clobetasol propionate, USP, a synthetic corticosteroid, for topical 9 dermatologic use 15 The following is the chemical structure: 16 17 18 Clobetasol propionate 19 20 Clobetasol propionate is a white or almost...
http://www.fda.gov/cder/foi/label/2000/21142lbl.pdf page 2