Drug Approval Package FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Benzamycin Pak (Erythromycin 3%-Benzoyl Peroxide 5%) Topical Gel Company:- Dermik Laboratories Application No.:- 050769 Approval Date:-11/27/2000 Approval Letter(s) - - Printed Labeling - - Medical Review(s) - Chemistry Review(s) - - Pharmacology Review(s) -...
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,...
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 VULGARIS...
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...
Drug Approvals - B Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Bacitracin Injection, 50,000 units/vial, Rx American Pharmaceutical Partners ANDA 65-116 12/3/02 - - - Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP, Rx Altana, IncBenzamycin (erythromycin, 3% and benzoyl peroxide, 5%) Topical Gel,- Dermik Laboratories,...
1998 Warning Letters and Untitled Letters to Pharmaceutical Companies DMPQ 8/24 9/8 Trivora (Levonorgestrel and Ethinyl Estradiol) Tablets Watson Laboratories DDMAC 8/6 8/11 Trusopt (Dorzolamide HCL) Ophthalmic Solution Merck DDMAC 8/20 8/25 Vanceril Schering Corporation DDMAC 8/24 10/22 September Aldara (imiquimod) Cream 3M Pharmaceuticals DDMAC 9/29 11/3 Allegra (Fexofenadine HCl) Hoechst Marion Roussel DDMAC 9/23 9/28 Avapro (Irbesatan) Tablets...
http://www.dermik.com/prod/benzamycin/Benzamy_Ins_50056674.pdf Benzamycin ® Pak (erythromycin 3%- benzoyl peroxide 5% topical gel) For Dermatological Use Only – Not for Ophthalmic Use DESCRIPTION Benzamycin ® Pak contains erythromycin [( 3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)- 4[( 2,6- dideoxy- 3- C- methyl- 3- O- methyl- a- L- ribo- hexopyranosyl)- oxy]- 14- ethyl- 7,12,13- trihydroxy3,5...
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DOCUMENT INFORMATION PAGE page 1
author: CDER USER
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt "PSEUDOEPHEDRINE HYDROCHLORIDE AS MFG IN HESHOU COUNTY, XINJIANG, CHINA." 15333 30-Mar-01 DEGUSSA-HULS AG "N6-TRIFLUORACETYL-L-LYSYL-L-PROLINE MANUFACTURED IN HANAU AND RADEBEUL, GERMANY." 15335 15-Mar-01 RP SCHERER NORTH AMERICA "LANOXICAPS (0.5, 0.10, AND 0.20MG) SOFTGEL CAPSULES AS MFG IN ST.PETERSBURG, FL." 15337 19-Mar-01 SPI PHARMA "MAGNESIUM HYDROXIDE PASTE/POWDER USP AS MFG...
1172Vol11.1 Acne Often- used active ingredients include benzoyl peroxide (2.5 to 10%), salicylic acid (0.5% to 2%), sulfur (3% to 8%) and a combination of sulfur (3- 8%) with either resorcinol (2%) or resorcinol monoacetate (3%), glycolic acid, retinoic acid (0.01% to 0.1%) and various antibiotics, such as tetracycline and erythromycin Benzoyl peroxide also has irritant, drying...
author: SilverStreak
1172Vol11.1 Acne page 3
author: SilverStreak
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- phosphate)Benzoyl ...
author: steve
Contents Vol. 22, No. 7, 2002 Contents Editorial Policies and Procedures for Submitted Original Research iii Original Research Articles Pharmacokinetics of the Generic Formulation Propofol 1% Fresenius in Comparison with the Original Formulation (Disoprivan ® 1%) 417- 427 C Jungheinrich, R Scharpf, M Wargenau, C Dilger, F Bepperling Effects of Oral Contraceptives on the Pharmacokinetics of Moxifloxacin in...
author: Adis International Limited
subject: Clinical Drug Investigation
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 reduction in total...
author: Mary Jean Kozma Fornaro
Medicines, Ethics and Practice page 5
