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Last Updated: June 21, 2024

Details for New Drug Application (NDA): 077236

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NDA 077236 describes PREDNICARBATE, which is a drug marketed by Fougera Pharms and is included in two NDAs. It is available from one supplier. Additional details are available on the PREDNICARBATE profile page.

The generic ingredient in PREDNICARBATE is prednicarbate. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the prednicarbate profile page.
Summary for 077236
Applicant:Fougera Pharms
Formulation / Manufacturing:see details
Pharmacology for NDA: 077236
Suppliers and Packaging for NDA: 077236
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREDNICARBATE prednicarbate OINTMENT;TOPICAL 077236 ANDA Fougera Pharmaceuticals Inc. 0168-0410 0168-0410-15 15 g in 1 TUBE (0168-0410-15)
PREDNICARBATE prednicarbate OINTMENT;TOPICAL 077236 ANDA Fougera Pharmaceuticals Inc. 0168-0410 0168-0410-60 60 g in 1 TUBE (0168-0410-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.1%
Approval Date:Mar 9, 2007TE:RLD:No

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