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Generated: November 17, 2018

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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-five 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 020453
Tradename:PANDEL
Applicant:Fougera Pharms
Ingredient:hydrocortisone probutate
Patents:0
Pharmacology for NDA: 020453
Suppliers and Packaging for NDA: 020453
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PANDEL 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
PANDEL 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

Profile for product number 001

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

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