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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 207647

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NDA 207647 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 207647

Tradename:	ERTAPENEM SODIUM
Applicant:	Savior Lifetec Corp
Ingredient:	ertapenem sodium
Patents:	0

Pharmacology for NDA: 207647

Suppliers and Packaging for NDA: 207647

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	207647	ANDA	Savior Lifetec Corporation	44647-051	44647-051-10	10 VIAL in 1 CARTON (44647-051-10) / 20 mL in 1 VIAL (44647-051-01)
ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	207647	ANDA	Apotex Corp	60505-6196	60505-6196-4	10 VIAL in 1 CARTON (60505-6196-4) / 20 mL in 1 VIAL (60505-6196-0)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS			Strength	EQ 1GM BASE/VIAL
Approval Date:	Mar 19, 2019	TE:	AP	RLD:	No

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