Details for New Drug Application (NDA): 021337

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NDA 021337 describes INVANZ, which is a drug marketed by Msd Sub Merck and is included in one NDA. It is available from two suppliers. Additional details are available on the INVANZ profile page.

The generic ingredient in INVANZ is ertapenem sodium. There are eight drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ertapenem sodium profile page.

Summary for 021337

Tradename:	INVANZ
Applicant:	Msd Sub Merck
Ingredient:	ertapenem sodium
Patents:	0

Pharmacology for NDA: 021337

Suppliers and Packaging for NDA: 021337

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
INVANZ	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	021337	NDA	Merck Sharp & Dohme LLC	0006-3843	0006-3843-71	10 VIAL, SINGLE-DOSE in 1 PACKAGE (0006-3843-71) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
INVANZ	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	021337	NDA	ENDO USA, Inc.	42023-221	42023-221-10	10 VIAL, SINGLE-DOSE in 1 PACKAGE (42023-221-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (42023-221-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS			Strength	EQ 1GM BASE/VIAL
Approval Date:	Nov 21, 2001	TE:	AP	RLD:	Yes

Expired US Patents for NDA 021337

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	INVANZ	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	021337-001	Nov 21, 2001	⤷ Sign Up	⤷ Sign Up
Msd Sub Merck	INVANZ	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	021337-001	Nov 21, 2001	⤷ Sign Up	⤷ Sign Up
Msd Sub Merck	INVANZ	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	021337-001	Nov 21, 2001	⤷ Sign Up	⤷ Sign Up
Msd Sub Merck	INVANZ	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	021337-001	Nov 21, 2001	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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