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Generated: August 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065443

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NDA 065443 describes CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, which is a drug marketed by Actavis Labs Ut Inc, Perrigo Israel, Mylan Pharms Inc, and Tolmar, and is included in six NDAs. It is available from four suppliers. Additional details are available on the CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE profile page.

The generic ingredient in CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE is benzoyl peroxide; clindamycin phosphate. There are seventeen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.

Summary for NDA: 065443

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 065443

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL 065443 ANDA Mylan Pharmaceuticals Inc. 0378-8688 0378-8688-35 1 KIT in 1 CARTON (0378-8688-35) * 40 g in 1 JAR * 10 g in 1 BOTTLE, PLASTIC * 20 g in 1 JAR * 5 g in 1 BOTTLE, PLASTIC
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL 065443 ANDA Mylan Pharmaceuticals Inc. 0378-8688 0378-8688-54 1 KIT in 1 CARTON (0378-8688-54) * 40 g in 1 JAR * 10 g in 1 BOTTLE, PLASTIC * 20 g in 1 JAR * 5 g in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength5%;EQ 1% BASE
Approval Date:Aug 11, 2009TE:ABRLD:No


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