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Last Updated: December 22, 2024

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 Pharma Ltd, Qilu, Savior Lifetec Corp, and Sun Pharm, and is included in six NDAs. It is available from thirteen 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. Fifteen 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:RXDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 1GM BASE/VIAL
Approval Date:Mar 19, 2019TE:APRLD:No

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