Last Updated: August 9, 2026

Drugs in MeSH Category Teratogens

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-003	May 25, 2012	AB2	RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Upsher Smith Labs	ISOTRETINOIN	isotretinoin	CAPSULE;ORAL	213571-001	Apr 12, 2021	AB2	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Sun Pharm	ABSORICA LD	isotretinoin	CAPSULE;ORAL	211913-001	Nov 5, 2019		RX	Yes	No	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Sun Pharm Inds Ltd	SOTRET	isotretinoin	CAPSULE;ORAL	076041-003	Dec 24, 2002		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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