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Generated: August 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075224

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NDA 075224 describes CLOBETASOL PROPIONATE, which is a drug marketed by Perrigo Israel, Taro, Wockhardt, Fougera Pharms, Akorn, Actavis Mid Atlantic, Perrigo Co, G And W Labs Inc, Glenmark Pharms, Mylan Pharms Inc, Teligent Pharma Inc, Novel Labs Inc, Tolmar, Zydus Pharms Usa Inc, Teva Pharms Usa, Fougera Pharms Inc, Paddock Llc, and Ingenus Pharms Llc, and is included in thirty-five NDAs. It is available from twenty-five 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-two suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

Summary for NDA: 075224

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

Pharmacology for NDA: 075224

Suppliers and Packaging for NDA: 075224

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOBETASOL PROPIONATE
clobetasol propionate
SOLUTION;TOPICAL 075224 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1293 51672-1293-2 1 BOTTLE, PLASTIC in 1 CARTON (51672-1293-2) > 25 mL in 1 BOTTLE, PLASTIC
CLOBETASOL PROPIONATE
clobetasol propionate
SOLUTION;TOPICAL 075224 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1293 51672-1293-3 1 BOTTLE, PLASTIC in 1 CARTON (51672-1293-3) > 50 mL in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength0.05%
Approval Date:Nov 16, 1998TE:ATRLD:No


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Serving 500+ biopharmaceutical companies globally:

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Moodys
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Federal Trade Commission
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UBS

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