Last Updated: September 24, 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
Zydus Pharms	ISOTRETINOIN	isotretinoin	CAPSULE;ORAL	211568-004	Aug 29, 2023	AB1	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Teva Pharms Usa	CLARAVIS	isotretinoin	CAPSULE;ORAL	076135-003	May 11, 2006	AB1	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-002	May 25, 2012	AB2	RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Upsher Smith Labs	ISOTRETINOIN	isotretinoin	CAPSULE;ORAL	212333-001	Sep 21, 2021	AB2	RX	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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