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

Tradename:	PANDEL
Applicant:	Ani Pharms
Ingredient:	hydrocortisone probutate
Patents:	0

Pharmacology for NDA: 020453

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

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:	RX	Dosage:	CREAM;TOPICAL			Strength	0.1%
Approval Date:	Feb 28, 1997	TE:		RLD:	Yes

Expired US Patents for NDA 020453

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	PANDEL	hydrocortisone probutate	CREAM;TOPICAL	020453-001	Feb 28, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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