Details for New Drug Application (NDA): 019049

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NDA 019049 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 019049

Tradename:	RETIN-A
Applicant:	Bausch
Ingredient:	tretinoin
Patents:	0

Pharmacology for NDA: 019049

Medical Subject Heading (MeSH) Categories for 019049

Antineoplastic Agents
Keratolytic Agents

Suppliers and Packaging for NDA: 019049

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RETIN-A	tretinoin	CREAM;TOPICAL	019049	NDA	Bausch Health US, LLC	0187-5160	0187-5160-20	1 TUBE in 1 CARTON (0187-5160-20) / 20 g in 1 TUBE
RETIN-A	tretinoin	CREAM;TOPICAL	019049	NDA	Bausch Health US, LLC	0187-5160	0187-5160-45	1 TUBE in 1 CARTON (0187-5160-45) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.025%
Approval Date:	Sep 16, 1988	TE:	AB	RLD:	Yes

Expired US Patents for NDA 019049

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	RETIN-A	tretinoin	CREAM;TOPICAL	019049-001	Sep 16, 1988	⤷ Sign Up	⤷ Sign Up
Bausch	RETIN-A	tretinoin	CREAM;TOPICAL	019049-001	Sep 16, 1988	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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