Details for New Drug Application (NDA): 017340

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NDA 017340 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 017340

Tradename:	RETIN-A
Applicant:	Valeant Pharms North
Ingredient:	tretinoin
Patents:	0

Pharmacology for NDA: 017340

Medical Subject Heading (MeSH) Categories for 017340

Antineoplastic Agents
Keratolytic Agents

Suppliers and Packaging for NDA: 017340

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RETIN-A	tretinoin	CREAM;TOPICAL	017340	NDA	Bausch Health US, LLC	0187-5164	0187-5164-20	1 TUBE in 1 CARTON (0187-5164-20) / 20 g in 1 TUBE
RETIN-A	tretinoin	CREAM;TOPICAL	017340	NDA	Bausch Health US, LLC	0187-5164	0187-5164-45	1 TUBE in 1 CARTON (0187-5164-45) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.1%
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Expired US Patents for NDA 017340

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Pharms North	RETIN-A	tretinoin	CREAM;TOPICAL	017340-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Valeant Pharms North	RETIN-A	tretinoin	CREAM;TOPICAL	017340-001	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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