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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 021108

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NDA 021108 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 021108

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

Pharmacology for NDA: 021108

Medical Subject Heading (MeSH) Categories for 021108

Antineoplastic Agents
Keratolytic Agents

Suppliers and Packaging for NDA: 021108

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RENOVA	tretinoin	CREAM;TOPICAL	021108	NDA	Bausch Health US LLC	0187-5150	0187-5150-02	1 TUBE in 1 CARTON (0187-5150-02) / 2 g in 1 TUBE
RENOVA	tretinoin	CREAM;TOPICAL	021108	NDA	Bausch Health US LLC	0187-5150	0187-5150-20	1 TUBE in 1 CARTON (0187-5150-20) / 20 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.02%
Approval Date:	Aug 31, 2000	TE:		RLD:	Yes

Expired US Patents for NDA 021108

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	021108-001	Aug 31, 2000	4,603,146	⤷ Get Started Free
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	021108-001	Aug 31, 2000	RE36068	⤷ Get Started Free
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	021108-001	Aug 31, 2000	6,531,141	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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