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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 074513

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NDA 074513 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 074513

Tradename:	ETOPOSIDE
Applicant:	Accord Hlthcare
Ingredient:	etoposide
Patents:	0

Pharmacology for NDA: 074513

Mechanism of Action	Topoisomerase Inhibitors

Medical Subject Heading (MeSH) Categories for 074513

Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors

Suppliers and Packaging for NDA: 074513

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ETOPOSIDE	etoposide	INJECTABLE;INJECTION	074513	ANDA	Accord Healthcare Inc.	16729-114	16729-114-08	1 VIAL, MULTI-DOSE in 1 BOX (16729-114-08) / 25 mL in 1 VIAL, MULTI-DOSE
ETOPOSIDE	etoposide	INJECTABLE;INJECTION	074513	ANDA	Accord Healthcare Inc.	16729-114	16729-114-11	1 VIAL, MULTI-DOSE in 1 BOX (16729-114-11) / 50 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	20MG/ML
Approval Date:	Mar 14, 1996	TE:	AP	RLD:	No

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