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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 074813

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NDA 074813 describes ETOPOSIDE, which is a drug marketed by Mylan, Accord Hlthcare, Dash Pharms, Dash Pharms Natco, Fresenius Kabi Usa, Hikma, Hospira, Meitheal, Pharmachemie Bv, Pierre Fabre, Teva Parenteral, Teva Pharms Usa, Watson Labs, and Watson Labs Inc, and is included in fifteen NDAs. It is available from six suppliers. Additional details are available on the ETOPOSIDE profile page.

The generic ingredient in ETOPOSIDE is etoposide. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the etoposide profile page.

Summary for 074813

Tradename:	ETOPOSIDE
Applicant:	Pierre Fabre
Ingredient:	etoposide
Patents:	0

Medical Subject Heading (MeSH) Categories for 074813

Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	20MG/ML
Approval Date:	Jul 9, 1997	TE:		RLD:	No

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