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Details for New Drug Application (NDA): 017955

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NDA 017955 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: 017955

Valeant Intl
Therapeutic Class:Antineoplastics
Dermatological Agents

Pharmacology for NDA: 017955


Suppliers and Packaging for NDA: 017955

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEL;TOPICAL 017955 NDA Ortho-McNeil Pharmaceuticals 0062-0575 0062-0575-46 1 TUBE in 1 CARTON (0062-0575-46) > 45 g in 1 TUBE
GEL;TOPICAL 017955 NDA Valeant Pharmaceuticals North America LLC 0187-5172 0187-5172-15 1 TUBE in 1 CARTON (0187-5172-15) > 15 g in 1 TUBE

Summary for product number 001

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

Expired Orange Book Patents for NDA: 017955

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Intl
GEL;TOPICAL017955-001Approved Prior to Jan 1, 19823,729,568<disabled>
Valeant Intl
GEL;TOPICAL017955-001Approved Prior to Jan 1, 19824,247,547<disabled>
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.