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Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075027

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NDA 075027 describes CLOBETASOL PROPIONATE, which is a drug marketed by Ingenus Pharms Llc, Perrigo Israel, Fougera Pharms Inc, G And W Labs Inc, Mylan Pharms Inc, Taro, Teva Pharms Usa, Fougera Pharms, Perrigo Co, Teligent Pharma Inc, Actavis Mid Atlantic, Lupin Ltd, Glenmark Pharms, Zydus Pharms Usa Inc, Hi-tech Pharmacal, Macleods Pharms Ltd, Novel Labs Inc, Tolmar, Wockhardt, Akorn, Paddock Llc, and Novast Labs Ltd, and is included in forty-one NDAs. It is available from thirty-one suppliers. Additional details are available on the CLOBETASOL PROPIONATE profile page.

The generic ingredient in CLOBETASOL PROPIONATE is clobetasol propionate. There are thirteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 075027
Tradename:CLOBETASOL PROPIONATE
Applicant:Perrigo Co
Ingredient:clobetasol propionate
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details
Pharmacology for NDA: 075027
Medical Subject Heading (MeSH) Categories for 075027
Suppliers and Packaging for NDA: 075027
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOBETASOL PROPIONATE clobetasol propionate GEL;TOPICAL 075027 ANDA Perrigo New York Inc 45802-925 45802-925-96 1 TUBE in 1 CARTON (45802-925-96) > 60 g in 1 TUBE
CLOBETASOL PROPIONATE clobetasol propionate GEL;TOPICAL 075027 ANDA Perrigo New York Inc 45802-925 45802-925-94 1 TUBE in 1 CARTON (45802-925-94) > 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.05%
Approval Date:Oct 31, 1997TE:ABRLD:No

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Moodys
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Cipla
Argus Health
Johnson and Johnson
McKesson
McKinsey
Queensland Health
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