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Last Updated: November 2, 2024

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 thirteen drug master file entries for this compound. Twelve 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
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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 018662-004 Mar 28, 1983 ⤷  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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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