Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 15, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017955

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NDA 017955 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 four 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 suppliers are listed for this compound. Additional details are available on the tretinoin profile page.
Summary for 017955
Tradename:RETIN-A
Applicant:Valeant Intl
Ingredient:tretinoin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 017955
Medical Subject Heading (MeSH) Categories for 017955
Suppliers and Packaging for NDA: 017955
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RETIN-A tretinoin GEL;TOPICAL 017955 NDA Bausch Health US LLC 0187-5172 0187-5172-15 1 TUBE in 1 CARTON (0187-5172-15) > 15 g in 1 TUBE
RETIN-A tretinoin GEL;TOPICAL 017955 NDA Bausch Health US LLC 0187-5172 0187-5172-45 1 TUBE in 1 CARTON (0187-5172-45) > 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.01%
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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