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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 017522

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NDA 017522 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 017522

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

Pharmacology for NDA: 017522

Medical Subject Heading (MeSH) Categories for 017522

Antineoplastic Agents
Keratolytic Agents

Suppliers and Packaging for NDA: 017522

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RETIN-A	tretinoin	CREAM;TOPICAL	017522	NDA	Bausch Health US, LLC	0187-5162	0187-5162-20	1 TUBE in 1 CARTON (0187-5162-20) / 20 g in 1 TUBE
RETIN-A	tretinoin	CREAM;TOPICAL	017522	NDA	Bausch Health US, LLC	0187-5162	0187-5162-45	1 TUBE in 1 CARTON (0187-5162-45) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.05%
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB1	RLD:	Yes

Expired US Patents for NDA 017522

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Bermuda	RETIN-A	tretinoin	CREAM;TOPICAL	017522-001	Approved Prior to Jan 1, 1982	⤷ Get Started Free	⤷ Get Started Free
Valeant Bermuda	RETIN-A	tretinoin	CREAM;TOPICAL	017522-001	Approved Prior to Jan 1, 1982	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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