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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 090974


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NDA 090974 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 Speclt, 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, Apotex, Sciegen Pharms Inc, Eyenovia, and Ani Pharms, and is included in eighty-one NDAs. It is available from thirty-seven suppliers. There are two patents protecting this drug. 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 suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 090974
Tradename:CLOBETASOL PROPIONATE
Applicant:Padagis Israel
Ingredient:clobetasol propionate
Patents:0
Pharmacology for NDA: 090974
Medical Subject Heading (MeSH) Categories for 090974
Suppliers and Packaging for NDA: 090974
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOBETASOL PROPIONATE clobetasol propionate SHAMPOO;TOPICAL 090974 ANDA Medimetriks Pharmaceuticals 43538-950 43538-950-04 1 BOTTLE in 1 CARTON (43538-950-04) / 118 mL in 1 BOTTLE
CLOBETASOL PROPIONATE clobetasol propionate SHAMPOO;TOPICAL 090974 ANDA Padagis Israel Pharmaceuticals Ltd 45802-961 45802-961-26 118 mL in 1 BOTTLE (45802-961-26)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SHAMPOO;TOPICALStrength0.05%
Approval Date:Aug 9, 2012TE:ABRLD:No

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