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Generated: September 22, 2017

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Details for New Drug Application (NDA): 089472

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NDA 089472 describes U-CORT, which is a drug marketed by Taro and is included in one NDA. It is available from one supplier. Additional details are available on the U-CORT profile page.

The generic ingredient in U-CORT is hydrocortisone acetate; urea. There are sixty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the hydrocortisone acetate; urea profile page.

Summary for NDA: 089472

Formulation / Manufacturing:see details

Pharmacology for NDA: 089472

Suppliers and Packaging for NDA: 089472

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
hydrocortisone acetate; urea
CREAM;TOPICAL 089472 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-3009 51672-3009-2 1 TUBE in 1 CARTON (51672-3009-2) > 28.35 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%;10%
Approval Date:Jun 13, 1988TE:RLD:No

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Serving 500+ biopharmaceutical companies globally:

Argus Health
Queensland Health
Harvard Business School
Daiichi Sankyo
Fish and Richardson
Johnson and Johnson

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