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Serving leading biopharmaceutical companies globally:

Baxter
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Merck
Daiichi Sankyo
Moodys
US Department of Justice
Colorcon
Healthtrust
Medtronic
McKinsey

Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075057

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NDA 075057 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 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-six suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

Summary for 075057

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 075057

Medical Subject Heading (MeSH) Categories for 075057

Suppliers and Packaging for NDA: 075057

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOBETASOL PROPIONATE clobetasol propionate OINTMENT;TOPICAL 075057 ANDA Mylan Pharmaceuticals Inc. 0378-8190 0378-8190-60 1 TUBE in 1 CARTON (0378-8190-60) > 60 g in 1 TUBE
CLOBETASOL PROPIONATE clobetasol propionate OINTMENT;TOPICAL 075057 ANDA Mylan Pharmaceuticals Inc. 0378-8190 0378-8190-30 1 TUBE in 1 CARTON (0378-8190-30) > 30 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.05%
Approval Date:Aug 12, 1998TE:AB1RLD:No


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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim
Argus Health
Mallinckrodt
Moodys
Colorcon
Novartis
Baxter
Chinese Patent Office
Queensland Health

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