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Last Updated: July 6, 2020

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Drugs in MeSH Category Alkylating Agents

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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
Aspen Global MYLERAN busulfan TABLET;ORAL 009386-001 Approved Prior to Jan 1, 1982 RX Yes Yes   Start Trial   Start Trial   Start Trial
Urogen Pharma JELMYTO mitomycin POWDER;PYELOCALYCEAL 211728-001 Apr 15, 2020 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Apotex BUSULFAN busulfan INJECTABLE;INJECTION 210448-001 May 7, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Luitpold BUSULFAN busulfan INJECTABLE;INJECTION 202259-001 Dec 22, 2015 AP RX No No   Start Trial   Start Trial   Start Trial
Helsinn VALCHLOR mechlorethamine hydrochloride GEL;TOPICAL 202317-001 Aug 23, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
West-ward Pharms Int MITOMYCIN mitomycin INJECTABLE;INJECTION 064180-001 Dec 23, 1999 AP 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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