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Generated: November 15, 2018

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Details for New Drug Application (NDA): 074904

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NDA 074904 describes TOPICORT, which is a drug marketed by Taro Pharm Inds Ltd and Taro Pharms and is included in ten NDAs. It is available from two suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TOPICORT profile page.

The generic ingredient in TOPICORT is desoximetasone. There are seven drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the desoximetasone profile page.
Summary for 074904
Tradename:TOPICORT
Applicant:Taro Pharm Inds Ltd
Ingredient:desoximetasone
Patents:0
Pharmacology for NDA: 074904
Medical Subject Heading (MeSH) Categories for 074904
Suppliers and Packaging for NDA: 074904
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOPICORT desoximetasone GEL;TOPICAL 074904 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1261 51672-1261-1 1 TUBE in 1 CARTON (51672-1261-1) > 15 g in 1 TUBE
TOPICORT desoximetasone GEL;TOPICAL 074904 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1261 51672-1261-2 1 TUBE in 1 CARTON (51672-1261-2) > 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.05%
Approval Date:Jul 14, 1998TE:ABRLD:No

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