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Serving leading biopharmaceutical companies globally:

Medtronic
Federal Trade Commission
Cipla
Chinese Patent Office
McKesson
Covington
Moodys
Boehringer Ingelheim
Fish and Richardson
Harvard Business School

Generated: October 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077287

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NDA 077287 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. Four suppliers are listed for this compound. Additional details are available on the prednicarbate profile page.

Summary for NDA: 077287

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 077287

Suppliers and Packaging for NDA: 077287

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREDNICARBATE
prednicarbate
CREAM;TOPICAL 077287 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0381 0168-0381-15 15 g in 1 TUBE (0168-0381-15)
PREDNICARBATE
prednicarbate
CREAM;TOPICAL 077287 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0381 0168-0381-60 60 g in 1 TUBE (0168-0381-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.1%
Approval Date:Sep 19, 2006TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Citi
Covington
QuintilesIMS
Dow
Boehringer Ingelheim
UBS
Medtronic
Colorcon
Fuji

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