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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 074027


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NDA 074027 describes DESONIDE, which is a drug marketed by Alembic, Cadila, Cosette, Glenmark Pharms, Padagis Us, Taro, Cintex Svcs, Fougera Pharms, Pai Holdings Pharm, Encube Ethicals, Glenmark Pharms Ltd, and Hikma, and is included in twenty NDAs. It is available from fourteen suppliers. Additional details are available on the DESONIDE profile page.

The generic ingredient in DESONIDE is desonide. There are thirty-one drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the desonide profile page.
Summary for 074027
Tradename:DESONIDE
Applicant:Cosette
Ingredient:desonide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 074027
Medical Subject Heading (MeSH) Categories for 074027
Suppliers and Packaging for NDA: 074027
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESONIDE desonide CREAM;TOPICAL 074027 ANDA Cosette Pharmaceuticals, Inc. 0713-0661 0713-0661-15 1 TUBE in 1 CARTON (0713-0661-15) / 15 g in 1 TUBE
DESONIDE desonide CREAM;TOPICAL 074027 ANDA Cosette Pharmaceuticals, Inc. 0713-0661 0713-0661-60 1 TUBE in 1 CARTON (0713-0661-60) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.05%
Approval Date:Sep 28, 1992TE:ABRLD:No

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