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Generated: January 23, 2019

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Details for New Drug Application (NDA): 073193

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NDA 073193 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 073193
Applicant:Taro Pharm Inds Ltd
Pharmacology for NDA: 073193
Medical Subject Heading (MeSH) Categories for 073193
Suppliers and Packaging for NDA: 073193
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOPICORT desoximetasone CREAM;TOPICAL 073193 ANDA Rebel Distributors Corp 42254-015 42254-015-60 1 TUBE in 1 CARTON (42254-015-60) > 60 g in 1 TUBE
TOPICORT desoximetasone CREAM;TOPICAL 073193 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1270 51672-1270-1 1 TUBE in 1 CARTON (51672-1270-1) > 15 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.25%
Approval Date:Nov 30, 1990TE:ABRLD:No

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