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Details for New Drug Application (NDA): 091314

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NDA 091314 describes ADAPALENE, which is a drug marketed by Actavis Mid Atlantic, Glenmark Generics, Taro, Fougera Pharms, Pliva Hrvatska Doo, Call Inc, and Tolmar, and is included in nine NDAs. It is available from twelve suppliers. Additional details are available on the ADAPALENE profile page.

The generic ingredient in ADAPALENE is adapalene; benzoyl peroxide. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the adapalene; benzoyl peroxide profile page.

Summary for NDA: 091314

Glenmark Generics
Therapeutic Class:Dermatological Agents

Pharmacology for NDA: 091314


Suppliers and Packaging for NDA: 091314

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEL;TOPICAL 091314 ANDA PruGen, Inc. 42546-720 42546-720-45 1 TUBE in 1 CARTON (42546-720-45) > 45 g in 1 TUBE
GEL;TOPICAL 091314 ANDA Glenmark Pharmaceuticals Inc., USA 68462-403 68462-403-55 45 g in 1 TUBE (68462-403-55)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.1%
Approval Date:Jul 1, 2010TE: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.