Last Updated: November 9, 2026

Details for New Drug Application (NDA): 020453

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

The generic ingredient in PANDEL is hydrocortisone probutate. There is one drug master file entry 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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	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	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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