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Federal Trade Commission
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Generated: February 19, 2018

DrugPatentWatch Database Preview

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 two suppliers. There is one patent protecting this drug. Additional details are available on the RENOVA profile page.

The generic ingredient in RENOVA is tretinoin. There are twenty-four drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the tretinoin profile page.
Summary for 021108
Applicant:Valeant Pharms North
Therapeutic Class:Antineoplastics
Dermatological Agents
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 Valeant Pharmaceuticals North America LLC 0187-5150 N 0187-5150-44
RENOVA tretinoin CREAM;TOPICAL 021108 NDA Valeant Pharmaceuticals North America LLC 0187-5150 N 0187-5150-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.02%
Approval Date:Aug 31, 2000TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Mar 7, 2020Product Flag?Substance Flag?Delist Request?

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