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Last Updated: October 7, 2022

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 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021108
Medical Subject Heading (MeSH) Categories for 021108
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:RXDosage:CREAM;TOPICALStrength0.02%
Approval Date:Aug 31, 2000TE:RLD:Yes

Expired US Patents for NDA 021108

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms North RENOVA tretinoin CREAM;TOPICAL 021108-001 Aug 31, 2000 See Plans and Pricing See Plans and Pricing
Valeant Pharms North RENOVA tretinoin CREAM;TOPICAL 021108-001 Aug 31, 2000 See Plans and Pricing See Plans and Pricing
Valeant Pharms North RENOVA tretinoin CREAM;TOPICAL 021108-001 Aug 31, 2000 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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