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Last Updated: May 14, 2021

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, Anda Repository, Glenmark Pharms, Mylan Pharms Inc, Perrigo Israel, Perrigo Uk Finco, Taro, Taro Pharms, Tolmar, and Zydus Pharms, and is included in fourteen NDAs. It is available from ten 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. Fourteen suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.
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 0378-8688-54 1 KIT in 1 CARTON (0378-8688-54) * 10 g in 1 BOTTLE, PLASTIC * 40 g in 1 JAR
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) * 5 g in 1 BOTTLE, PLASTIC * 20 g in 1 JAR

Profile 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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