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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 five 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. Nine suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.

Summary for NDA: 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 0378-8688-35 1 KIT in 1 CARTON (0378-8688-35) * 20 g in 1 JAR * 10 g in 1 BOTTLE, PLASTIC * 40 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) * 20 g in 1 JAR * 10 g in 1 BOTTLE, PLASTIC * 40 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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