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Last Updated: April 22, 2024

Details for New Drug Application (NDA): 017340


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NDA 017340 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 017340
Tradename:RETIN-A
Applicant:Valeant Pharms North
Ingredient:tretinoin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 017340
Medical Subject Heading (MeSH) Categories for 017340
Suppliers and Packaging for NDA: 017340
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RETIN-A tretinoin CREAM;TOPICAL 017340 NDA Bausch Health US, LLC 0187-5164 0187-5164-20 1 TUBE in 1 CARTON (0187-5164-20) / 20 g in 1 TUBE
RETIN-A tretinoin CREAM;TOPICAL 017340 NDA Bausch Health US, LLC 0187-5164 0187-5164-45 1 TUBE in 1 CARTON (0187-5164-45) / 45 g in 1 TUBE

Profile for product number 001

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

Expired US Patents for NDA 017340

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms North RETIN-A tretinoin CREAM;TOPICAL 017340-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Valeant Pharms North RETIN-A tretinoin CREAM;TOPICAL 017340-001 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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