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Federal Trade Commission
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Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018662

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NDA 018662 describes ACCUTANE, which is a drug marketed by Hoffmann La Roche and is included in one NDA. Additional details are available on the ACCUTANE profile page.

The generic ingredient in ACCUTANE is isotretinoin. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.
Summary for 018662
Tradename:ACCUTANE
Applicant:Hoffmann La Roche
Ingredient:isotretinoin
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 018662

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:May 7, 1982TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:May 7, 1982TE:RLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 28, 1983TE:RLD:Yes

Expired US Patents for NDA 018662

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-003 May 7, 1982 ➤ Sign Up ➤ Sign Up
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-002 May 7, 1982 ➤ Sign Up ➤ Sign Up
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-003 May 7, 1982 ➤ Sign Up ➤ Sign Up
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-002 May 7, 1982 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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