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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 016921

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NDA 016921 describes RETIN-A, which is a drug marketed by Bausch, Valeant Bermuda, Valeant Pharms North, and Valeant Intl, and is included in seven NDAs. It is available from four suppliers. Additional details are available on the RETIN-A profile page.

The generic ingredient in RETIN-A is tretinoin. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

Summary for 016921

Tradename:	RETIN-A
Applicant:	Valeant Intl
Ingredient:	tretinoin
Patents:	0

Medical Subject Heading (MeSH) Categories for 016921

Antineoplastic Agents
Keratolytic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;TOPICAL			Strength	0.05%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SWAB;TOPICAL			Strength	0.05%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Expired US Patents for NDA 016921

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Intl	RETIN-A	tretinoin	SOLUTION;TOPICAL	016921-001	Approved Prior to Jan 1, 1982	3,729,568	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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