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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 018594


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NDA 018594 describes TOPICORT, which is a drug marketed by Taro and is included in ten NDAs. It is available from two suppliers. There are two 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. Thirteen suppliers are listed for this compound. Additional details are available on the desoximetasone profile page.
Summary for 018594
Tradename:TOPICORT
Applicant:Taro
Ingredient:desoximetasone
Patents:0
Pharmacology for NDA: 018594
Medical Subject Heading (MeSH) Categories for 018594
Suppliers and Packaging for NDA: 018594
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOPICORT desoximetasone OINTMENT;TOPICAL 018594 NDA Taro Pharmaceuticals U.S.A., Inc. 51672-1352 51672-1352-1 1 TUBE in 1 CARTON (51672-1352-1) / 15 g in 1 TUBE
TOPICORT desoximetasone OINTMENT;TOPICAL 018594 NDA Taro Pharmaceuticals U.S.A., Inc. 51672-1352 51672-1352-2 1 TUBE in 1 CARTON (51672-1352-2) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.05%
Approval Date:Jan 17, 1985TE:ABRLD:Yes

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