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QuintilesIMS
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Federal Trade Commission
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Accenture
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Generated: June 23, 2018

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, Mylan Pharms Inc, Perrigo Israel, Taro, Taro Pharms, and Tolmar, and is included in nine NDAs. It is available from five 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. Eleven suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.
Summary for 065443
Tradename:CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Applicant:Mylan Pharms Inc
Ingredient:benzoyl peroxide; clindamycin phosphate
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 N 0378-8688-35
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 065443 ANDA Mylan Pharmaceuticals Inc. 0378-8688 N 0378-8688-54

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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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Queensland Health
Healthtrust
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Cipla
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