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Generated: April 24, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017522

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NDA 017522 describes RETIN-A, which is a drug marketed by Valeant Bermuda, Valeant Pharms North, and Valeant Intl, and is included in seven NDAs. It is available from five 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-four suppliers are listed for this compound. Additional details are available on the tretinoin profile page.
Summary for 017522
Tradename:RETIN-A
Applicant:Valeant Bermuda
Ingredient:tretinoin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 017522
Medical Subject Heading (MeSH) Categories for 017522
Suppliers and Packaging for NDA: 017522
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RETIN-A tretinoin CREAM;TOPICAL 017522 NDA Valeant Pharmaceuticals North America LLC 0187-5162 0187-5162-20 1 TUBE in 1 CARTON (0187-5162-20) > 20 g in 1 TUBE
RETIN-A tretinoin CREAM;TOPICAL 017522 NDA Valeant Pharmaceuticals North America LLC 0187-5162 0187-5162-45 1 TUBE in 1 CARTON (0187-5162-45) > 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.05%
Approval Date:Approved Prior to Jan 1, 1982TE:AB1RLD:Yes

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