Details for New Drug Application (NDA): 207647
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The generic ingredient in ERTAPENEM SODIUM 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 207647
Tradename: | ERTAPENEM SODIUM |
Applicant: | Savior Lifetec Corp |
Ingredient: | ertapenem sodium |
Patents: | 0 |
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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