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Generated: April 19, 2019

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Details for New Drug Application (NDA): 075751

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NDA 075751 describes DESONIDE, which is a drug marketed by G And W Labs Inc, Glenmark Pharms, Perrigo New York, Taro, Fougera Pharms, Taro Pharm, Teligent Pharma Inc, Encube Ethicals, Glenmark Pharms Ltd, and Hi-tech Pharmacal, and is included in fifteen NDAs. It is available from twelve 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. Twenty suppliers are listed for this compound. Additional details are available on the desonide profile page.
Summary for 075751
Tradename:DESONIDE
Applicant:Fougera Pharms
Ingredient:desonide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075751
Medical Subject Heading (MeSH) Categories for 075751
Suppliers and Packaging for NDA: 075751
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESONIDE desonide OINTMENT;TOPICAL 075751 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0309 0168-0309-15 1 TUBE in 1 CARTON (0168-0309-15) > 15 g in 1 TUBE
DESONIDE desonide OINTMENT;TOPICAL 075751 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0309 0168-0309-60 1 TUBE in 1 CARTON (0168-0309-60) > 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.05%
Approval Date:Mar 12, 2001TE:ABRLD:No

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