Details for New Drug Application (NDA): 017579

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NDA 017579 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-six suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

Summary for 017579

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

Pharmacology for NDA: 017579

Medical Subject Heading (MeSH) Categories for 017579

Antineoplastic Agents
Keratolytic Agents

Suppliers and Packaging for NDA: 017579

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RETIN-A	tretinoin	GEL;TOPICAL	017579	NDA	Bausch Health US, LLC	0187-5170	0187-5170-15	1 TUBE in 1 CARTON (0187-5170-15) / 15 g in 1 TUBE
RETIN-A	tretinoin	GEL;TOPICAL	017579	NDA	Bausch Health US, LLC	0187-5170	0187-5170-45	1 TUBE in 1 CARTON (0187-5170-45) / 45 g in 1 TUBE

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	0.025%
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Expired US Patents for NDA 017579

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Intl	RETIN-A	tretinoin	GEL;TOPICAL	017579-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Valeant Intl	RETIN-A	tretinoin	GEL;TOPICAL	017579-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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