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Generated: November 15, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017579

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NDA 017579 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 017579
Tradename:RETIN-A
Applicant:Valeant Intl
Ingredient:tretinoin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 017579
Ingredient-typeRetinoids
Medical Subject Heading (MeSH) Categories for 017579
Suppliers and Packaging for NDA: 017579
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RETIN-A tretinoin GEL;TOPICAL 017579 NDA Valeant Pharmaceuticals North America LLC 0187-5170 0187-5170-15 1 TUBE in 1 CARTON (0187-5170-15) > 15 g in 1 TUBE
RETIN-A tretinoin GEL;TOPICAL 017579 NDA Valeant Pharmaceuticals North America LLC 0187-5170 0187-5170-45 1 TUBE in 1 CARTON (0187-5170-45) > 45 g in 1 TUBE

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.025%
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Expired US Patents for NDA 017579

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Intl RETIN-A tretinoin GEL;TOPICAL 017579-002 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Intl RETIN-A tretinoin GEL;TOPICAL 017579-002 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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