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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 075635

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NDA 075635 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 five 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. Five suppliers are listed for this compound. Additional details are available on the etoposide profile page.

Summary for 075635

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

Pharmacology for NDA: 075635

Mechanism of Action	Topoisomerase Inhibitors

Medical Subject Heading (MeSH) Categories for 075635

Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors

Suppliers and Packaging for NDA: 075635

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ETOPOSIDE	etoposide	CAPSULE;ORAL	075635	ANDA	Mylan Pharmaceuticals Inc.	0378-3266	0378-3266-94	20 CAPSULE in 1 CARTON (0378-3266-94)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	Sep 19, 2001	TE:		RLD:	No

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