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...
C:\Data\My Documents\N50756.S007APltr.doc
Percent reductions in lesion counts after treatment for 10 weeks in these two studies are shown below: NDA 50- 756/ S- 007 Study 1 BenzaClin n= 120 Benzoyl peroxide n= 120 Clindamycin n= 120 Vehicle n= 120 Mean percent reduction in inflammatory lesion counts 46% 32% 16% + 3% Mean percent reduction in non- inflammatory lesion counts 22% 22% 9% +1% Mean percent...
author: Mary Jean Kozma Fornaro
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author: Mary Jean Kozma Fornaro
Prescription and OTC Drug Product List 12/2000
Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 12: December 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE - ADD - BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE TABLET; ORAL - ADD - GEL; TOPICAL OXYCODONE AND ACETAMINOPHEN - ADD - BENZACLIN ...
50756_Benzaclin
Food and Drug Administration Center for Drug Evaluation and Research Title Search BenzaClin (Clindamycin 1% and Benzoyl Peroxide 5%) Topical Gel Company:--Dermik Laboratories, Inc Application No.:--50-756 Approval Date:-12/21/2000 Approval Letter(s) - Printed Labeling Medical Review(s) - Chemistry Review(s) - Pharmacology Review(s) - Statistical...
author: USERNAME
benzaclin_PI.indd
BenzaClin Topical Gel (clindamycin benzoyl peroxide gel) Topical Gel: clindamycin (1%) as clindamycin phosphate, benzoyl peroxide (5%) For Dermatological Use Only Not for Ophthalmic Use *Reconstitute Before Dispensing* DESCRIPTION BenzaClin Topical Gel contains clindamycin phosphate, (7( S)- chloro- 7- deoxylincomycin- 2-...
author: steve
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
CLINDAMYCIN PHOSPHATE AS MFG IN ZHEJIANG CHINA 14801 24-Mar-00 ZHEJIANG HUAHAI PHARMACEUTICAL CHEM CO LTD LISINOPRIL DIHYDRATE(BULK) AS MFG IN ZHEJIANG PROVINCE PR OF CHINA 14802 22-Mar-00 ARCHIMICA SPA MINOCYCLINE HYDROCHLORIDE AS MFG IN ORIGGIO(VA)ITALY 14804 23-Mar-00 THE 2ND BRANCH FACTORY OF XIANJU PHARMACEUTICAL FACTORY NABUMETONE(BULK)AS MFG IN XIANJU ZHEJIANG...
Prescription and OTC Drug Product List 8/2002
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE -A- AA ABLE 300MG;30MG N40452 001 AUG 01, 2002 AUG NEWA -A- AA 300MG;60MG N40459 001 AUG 01, 2002 AUG NEWA ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE TABLET; ORAL ACETAMINOPHEN AND PENTAZOCINE HCL -A- AB AMIDE PHARM 650MG;EQ 25MG BASE...
Prescription and OTC Drug Product List 11/2000
Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 11: November 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - ADD - ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE AMOXICILLIN - ADD - TABLET; ORAL TABLET; ORAL - ADD - TRIZIVIR AMOXICILLIN - ADD - + GLAXO WELLCOME EQ 300MG BASE;150MG;300MG N21205 001 - ADD -...
FDA Drug Approvals List November 2000
- Drug Approvals for November 2000 Definitions and Notes Original New Drug Applications Original Application #: 050782 Approval Date: 27-NOV-00 Trade Name: TRADENAME Chemical Type: 3 Therapeutic Potential: S Dosage Form: GEL Applicant: TARGET RESEARCH ASSOCIATES Active Ingredient(s): CLINDAMYCIN PHOSPHATE OTC/RX Status: RX Indication(s): FOR ONCE A DAY TREATMENT OF ACNE...
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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author: Mary Jean Kozma Fornaro
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author: Mary Jean Kozma Fornaro
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author: Mary Jean Kozma Fornaro
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author: Mary Jean Kozma Fornaro
Drug Approvals - B
NDA 8-173/S-015 3/26/03 4/15/03 4/1/03 - Bentyl (dicyclomine hydrocholride) Injection,- Aventis Pharmaceuticals NDA 8-370/S-030 8/12/02 8/21/02 - - BenzaClin Topical Gel, Rx Dermik Laboratories NDA 50-756/S7 8/9/02 8/14/02 8/9/02 - BenzaClin Topical Gel, Rx Dermik Laboratories NDA 50-756 12/21/00 - - 11/20/02 - BenzaClin Indications:- Acne vulgaris Benzamycin ...
The Clinical Briefs Series
- Trouble navigating this site Earn up to 10 free AMA Category 1 CME credit hours Topics include: The Vermont Colorectal Project; Problems With HER2 Testing; Honing in on BRCA Genetic Testing; Multifocal Breast Cancer; Prednisone Myeloma Remission; and much more Clinical Briefs in Pharmacology, Volume 11 (newly updated for 2003) Abstracts, commentary, and original articles...
Contents Vol. 3, No. 5, 2002
Contents Current Opinion Vitiligo: A Manifestation of Apoptosis 301- 308 CL Huang, JJ Nordlund, R Boissy Leading Articles Human Herpesvirus 7 in Dermatology: What Role Does it Play 309- 315 W Kempf Self- Tanning Lotions: Are They a Healthy Way to Achieve a Tan 317- 318 ZD Draelos Therapy in Practice Cutaneous Tuberculosis: Diagnosis and Treatment 319- 328 J Barbagallo, P...
author: Adis International Limited
subject: American Journal of Clinical Dermatology
Contents Vol. 2, No. 1, 2001
1- 6 S Chari, L Clark- Loeser, J Shupack, K Washenik Electronic Monitoring in Medication Adherence Measurement: Implications for Dermatology 7- 12 AM Koehler, HI Maibach Review Articles Potential of Honey in the Treatment of Wounds and Burns 13- 19 PC Molan Laser Removal of Tattoos 21- 25 M Kuperman- Beade, VJ Levine R Ashinoff Treatment of Urticaria: An Evidence- Based Evaluation of...
author: Adis International Limited
subject: American Journal of Clinical Dermatology
Contents Vol. 2, No. 4, 2001
Contents Therapy in Practice Leprosy: Recognition and Treatment 203- 211 M Ramos- e- Silva, P Frassinetti Bessa Rebello Review Articles Exogenous Ochronosis: An Update on Clinical Features, Causative Agents and Treatment Options 213- 217 CY Levin, H Maibach Clinical Applications for Maggots in Wound Care 219- 227 KY Mumcuoglu Role of Lasers and Photodynamic Therapy in the Treatment...
author: Adis International Limited
subject: American Journal of Clinical Dermatology
Drug Approvals - D
ANDA 74-904 7/14/98 7/14/98 - 3/16/99 Desoxyn (methamphetamine HCl) Tablets and Desoxyn (methamphetamine HCl) Gradumet Tablets, 5 mg & 5 mg, 10 mg, and 15 mg, Rx- Abbott Laboratories NDA 5-378/S-020 12/6/01 4/3/03 Detrol LA Extended- Release Capsules, Rx Pharmacia and Upjohn NDA 21-228 /S5 1/15 /04 1/22/04 - Detrol LA Extended- Release Capsules, Rx Pharmacia and Upjohn NDA 21-228 /S4...
http://www.plantsci.cam.ac.uk/plantsci/admin/forms/ChemCategABC.pdf page 1
DEPARTMENT OF PLANT SCIENCES, University of Cambridge CONTROL OF SUBSTANCES HAZARDOUS TO HEALTH (1988) REGULATIONS Chemical Inventory (A, B, C ) Classified Laboratory Chemicals (Categories A, B and C on Experimental Risk Assessment form) The chemicals listed below have been classified as Category ...