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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 074290

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NDA 074290 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 074290

Tradename:	ETOPOSIDE
Applicant:	Hikma
Ingredient:	etoposide
Patents:	0

Pharmacology for NDA: 074290

Mechanism of Action	Topoisomerase Inhibitors

Medical Subject Heading (MeSH) Categories for 074290

Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors

Suppliers and Packaging for NDA: 074290

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ETOPOSIDE	etoposide	INJECTABLE;INJECTION	074290	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9376	0143-9376-01	1 VIAL in 1 BOX, UNIT-DOSE (0143-9376-01) / 5 mL in 1 VIAL
ETOPOSIDE	etoposide	INJECTABLE;INJECTION	074290	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9510	0143-9510-01	1 VIAL in 1 BOX, UNIT-DOSE (0143-9510-01) / 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	20MG/ML
Approval Date:	Jul 17, 1995	TE:	AP	RLD:	No

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