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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Harvard Business School

Generated: September 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020453

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NDA 020453 describes PANDEL, which is a drug marketed by Fougera Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the PANDEL profile page.

The generic ingredient in PANDEL is hydrocortisone probutate. There are sixty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the hydrocortisone probutate profile page.

Summary for NDA: 020453

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)

Pharmacology for NDA: 020453

Suppliers and Packaging for NDA: 020453

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
hydrocortisone probutate
CREAM;TOPICAL 020453 NDA PharmaDerm a division of Fougera Pharmaceuticals Inc. 10337-153 10337-153-46 1 TUBE in 1 CARTON (10337-153-46) > 45 g in 1 TUBE
hydrocortisone probutate
CREAM;TOPICAL 020453 NDA PharmaDerm a division of Fougera Pharmaceuticals Inc. 10337-153 10337-153-66 6 TUBE in 1 CARTON (10337-153-66) > 2 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.1%
Approval Date:Feb 28, 1997TE:RLD:Yes

Expired Orange Book Patents for NDA: 020453

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fougera Pharms
hydrocortisone probutate
CREAM;TOPICAL020453-001Feb 28, 1997► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Express Scripts
Fish and Richardson
Chinese Patent Office
Cantor Fitzgerald
Daiichi Sankyo
Federal Trade Commission

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