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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 218067

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NDA 218067 describes ERTAPENEM SODIUM, which is a drug marketed by Acs Dobfar Spa, Eugia Pharma, Gland, Qilu Antibiotics, Savior Lifetec Corp, and Sun Pharm, and is included in six NDAs. It is available from fifteen suppliers. Additional details are available on the ERTAPENEM SODIUM profile page.

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

Summary for 218067

Tradename:	ERTAPENEM SODIUM
Applicant:	Qilu Antibiotics
Ingredient:	ertapenem sodium
Patents:	0

Pharmacology for NDA: 218067

Suppliers and Packaging for NDA: 218067

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	218067	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9429	0143-9429-10	10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9429-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0143-9429-01)
ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	218067	ANDA	Sagent Pharmaceuticals	25021-199	25021-199-20	10 VIAL in 1 CARTON (25021-199-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS			Strength	EQ 1GM BASE/VIAL
Approval Date:	Oct 31, 2024	TE:	AP	RLD:	No

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