Last Updated: November 8, 2026

Drugs in MeSH Category Antineoplastic Agents, Alkylating

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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
Meitheal	THIOTEPA	thiotepa	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	216037-002	Dec 26, 2023	AP	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Baxter Hlthcare Corp	BENDAMUSTINE HYDROCHLORIDE	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	216078-001	Dec 15, 2022	AP	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Apotex	ALKERAN	melphalan	TABLET;ORAL	014691-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Cephalon	TREANDA	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	022249-004	Sep 13, 2013		DISCN	Yes	No	8,791,270*PED	⤷ Start Trial			Y	⤷ Start Trial
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;INTRAVENOUS	022249-001	Mar 20, 2008	AP	RX	Yes	Yes	8,883,836*PED	⤷ Start Trial			Y	⤷ 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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