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Dow
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Generated: August 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074089

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NDA 074089 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: 074089

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

Pharmacology for NDA: 074089

Suppliers and Packaging for NDA: 074089

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOBETASOL PROPIONATE
clobetasol propionate
OINTMENT;TOPICAL 074089 ANDA G&W Laboratories, Inc. 0713-0656 0713-0656-15 1 TUBE in 1 CARTON (0713-0656-15) > 15 g in 1 TUBE
CLOBETASOL PROPIONATE
clobetasol propionate
OINTMENT;TOPICAL 074089 ANDA G&W Laboratories, Inc. 0713-0656 0713-0656-31 1 TUBE in 1 CARTON (0713-0656-31) > 30 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.05%
Approval Date:Feb 16, 1994TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Harvard Business School
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Baxter
US Department of Justice
Moodys
Express Scripts
Daiichi Sankyo
Citi
AstraZeneca

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