Last Updated: November 8, 2026

Details for New Drug Application (NDA): 018662

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 is one drug master file entry for this compound. Thirteen 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

Dermatologic Agents
Teratogens

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 7, 1982	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 7, 1982	TE:		RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Mar 28, 1983	TE:		RLD:	Yes

Expired US Patents for NDA 018662

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-004	Mar 28, 1983	⤷ Start Trial	⤷ Start Trial
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-002	May 7, 1982	⤷ Start Trial	⤷ Start Trial
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-004	Mar 28, 1983	⤷ Start Trial	⤷ Start Trial
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-003	May 7, 1982	⤷ Start Trial	⤷ Start Trial
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-004	Mar 28, 1983	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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