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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 019963

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NDA 019963 describes RENOVA, which is a drug marketed by Valeant Pharms North and is included in two NDAs. It is available from one supplier. Additional details are available on the RENOVA profile page.

The generic ingredient in RENOVA 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 019963

Tradename:	RENOVA
Applicant:	Valeant Pharms North
Ingredient:	tretinoin
Patents:	0

Medical Subject Heading (MeSH) Categories for 019963

Antineoplastic Agents
Keratolytic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 29, 1995	TE:		RLD:	Yes

Expired US Patents for NDA 019963

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	019963-001	Dec 29, 1995	4,423,041	⤷ Get Started Free
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	019963-001	Dec 29, 1995	RE36068	⤷ Get Started Free
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	019963-001	Dec 29, 1995	4,877,805	⤷ Get Started Free
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	019963-001	Dec 29, 1995	4,603,146	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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