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Last Updated: December 7, 2023

Details for New Drug Application (NDA): 020453

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NDA 020453 describes PANDEL, which is a drug marketed by Ani 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-seven 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
Applicant:Ani Pharms
Ingredient:hydrocortisone probutate
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 ANI Pharmaceuticals, Inc. 62559-325 62559-325-26 6 TUBE in 1 CARTON (62559-325-26) / 2 g in 1 TUBE
PANDEL hydrocortisone probutate CREAM;TOPICAL 020453 NDA ANI Pharmaceuticals, Inc. 62559-325 62559-325-80 1 TUBE in 1 CARTON (62559-325-80) / 80 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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Serving leading biopharmaceutical companies globally:

Johnson and Johnson

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