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Details for New Drug Application (NDA): 017579

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NDA 017579 describes RETIN-A, which is a drug marketed by Valeant Intl, Valeant Bermuda, and Valeant Pharms North, and is included in seven NDAs. It is available from nine suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the RETIN-A profile page.

The generic ingredient in RETIN-A is tretinoin. There are twenty-four 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 NDA: 017579

Valeant Intl
Therapeutic Class:Antineoplastics
Dermatological Agents

Pharmacology for NDA: 017579


Suppliers and Packaging for NDA: 017579

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEL;TOPICAL 017579 NDA Ortho-McNeil Pharmaceuticals 0062-0475 0062-0475-42 1 TUBE in 1 CARTON (0062-0475-42) > 15 g in 1 TUBE
GEL;TOPICAL 017579 NDA Ortho-McNeil Pharmaceuticals 0062-0475 0062-0475-45 1 TUBE in 1 CARTON (0062-0475-45) > 45 g in 1 TUBE

Summary for product number 002

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

Expired Orange Book Patents for NDA: 017579

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Intl
GEL;TOPICAL017579-002Approved Prior to Jan 1, 19823,729,568<disabled>
Valeant Intl
GEL;TOPICAL017579-002Approved Prior to Jan 1, 19824,247,547<disabled>
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