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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 210208


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NDA 210208 describes CLOBETASOL PROPIONATE, which is a drug marketed by Alembic, Glenmark Pharms Ltd, Novast Labs, Padagis Israel, Taro, Amneal, Aurobindo Pharma Usa, Chartwell Rx, Cosette, Encube, Fougera Pharms Inc, Glenmark Pharms, Lupin Ltd, Pai Holdings Pharm, Rising, Teva Pharms Usa, Torrent, Xiromed, Zydus Pharms, Fougera Pharms, Padagis Us, Actavis Mid Atlantic, Epic Pharma Llc, Zydus Lifesciences, Macleods Pharms Ltd, Novel Labs Inc, Hikma, Prinston Inc, Quagen, Saptalis Pharms, Wockhardt Bio Ag, Akorn, Apotex, and Ani Pharms, and is included in seventy-nine NDAs. It is available from thirty-six suppliers. Additional details are available on the CLOBETASOL PROPIONATE profile page.

The generic ingredient in CLOBETASOL PROPIONATE is clobetasol propionate. There are fourteen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 210208
Tradename:CLOBETASOL PROPIONATE
Applicant:Lupin Ltd
Ingredient:clobetasol propionate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 210208
Medical Subject Heading (MeSH) Categories for 210208
Suppliers and Packaging for NDA: 210208
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOBETASOL PROPIONATE clobetasol propionate CREAM;TOPICAL 210208 ANDA Lupin Pharmaceuticals, Inc. 68180-956 68180-956-01 1 TUBE in 1 CARTON (68180-956-01) / 15 g in 1 TUBE
CLOBETASOL PROPIONATE clobetasol propionate CREAM;TOPICAL 210208 ANDA Lupin Pharmaceuticals, Inc. 68180-956 68180-956-02 1 TUBE in 1 CARTON (68180-956-02) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.05%
Approval Date:Jan 30, 2018TE:AB1RLD:No

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