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Last Updated: January 22, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210809

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NDA 210809 describes CLOBETASOL PROPIONATE, which is a drug marketed by Glenmark Pharms Ltd, Ingenus Pharms Llc, Perrigo Israel, Perrigo Uk Finco, Taro, Acp Nimble, Amneal Pharms Llc, Fougera Pharms Inc, Glenmark Pharms, Lupin Ltd, Mylan, Rising, Teligent Pharma Inc, Teva Pharms Usa, Xiromed, Zydus Pharms, Fougera Pharms, Perrigo Co, Actavis Mid Atlantic, Hi Tech, Aleor Dermaceuticals, Encube, Novel Labs Inc, Torrent, Macleods Pharms Ltd, Saptalis Pharms, Tolmar, Wockhardt Bio Ag, Akorn, Apotex, Paddock Llc, and Novast Labs, and is included in sixty-eight NDAs. It is available from forty-three 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-nine suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 210809
Applicant:Glenmark Pharms Ltd
Ingredient:clobetasol propionate
Formulation / Manufacturing:see details
Pharmacology for NDA: 210809
Medical Subject Heading (MeSH) Categories for 210809
Suppliers and Packaging for NDA: 210809
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOBETASOL PROPIONATE clobetasol propionate AEROSOL, FOAM;TOPICAL 210809 ANDA Glenmark Pharmaceuticals Inc., USA 68462-608 68462-608-27 50 g in 1 CAN (68462-608-27)
CLOBETASOL PROPIONATE clobetasol propionate AEROSOL, FOAM;TOPICAL 210809 ANDA Glenmark Pharmaceuticals Inc., USA 68462-608 68462-608-94 100 g in 1 CAN (68462-608-94)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, FOAM;TOPICALStrength0.05%
Approval Date:Feb 15, 2019TE:AB1RLD:No

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