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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 017955


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NDA 017955 describes RETIN-A, which is a drug marketed by Bausch, 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-two 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

Expired US Patents for NDA 017955

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Intl RETIN-A tretinoin GEL;TOPICAL 017955-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Valeant Intl RETIN-A tretinoin GEL;TOPICAL 017955-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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