Details for New Drug Application (NDA): 020457

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NDA 020457 describes ETOPOPHOS PRESERVATIVE FREE, which is a drug marketed by Bristol Myers Squibb and Cheplapharm and is included in two NDAs. It is available from one supplier. Additional details are available on the ETOPOPHOS PRESERVATIVE FREE profile page.

The generic ingredient in ETOPOPHOS PRESERVATIVE FREE is etoposide phosphate. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the etoposide phosphate profile page.

Summary for 020457

Tradename:	ETOPOPHOS PRESERVATIVE FREE
Applicant:	Cheplapharm
Ingredient:	etoposide phosphate
Patents:	0

Pharmacology for NDA: 020457

Mechanism of Action	Topoisomerase Inhibitors

Suppliers and Packaging for NDA: 020457

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ETOPOPHOS PRESERVATIVE FREE	etoposide phosphate	INJECTABLE;INJECTION	020457	NDA	H2-Pharma, LLC	61269-410	61269-410-20	1 VIAL, SINGLE-DOSE in 1 CARTON (61269-410-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 100MG BASE/VIAL
Approval Date:	May 17, 1996	TE:		RLD:	Yes

Expired US Patents for NDA 020457

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	ETOPOPHOS PRESERVATIVE FREE	etoposide phosphate	INJECTABLE;INJECTION	020457-001	May 17, 1996	⤷ Sign Up	⤷ Sign Up
Cheplapharm	ETOPOPHOS PRESERVATIVE FREE	etoposide phosphate	INJECTABLE;INJECTION	020457-001	May 17, 1996	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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