Details for New Drug Application (NDA): 209133
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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 209133
Tradename: | ERTAPENEM SODIUM |
Applicant: | Eugia Pharma |
Ingredient: | ertapenem sodium |
Patents: | 0 |
Suppliers and Packaging for NDA: 209133
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ERTAPENEM SODIUM | ertapenem sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 209133 | ANDA | Eugia US LLC | 55150-282 | 55150-282-20 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-282-20) / 1 INJECTION in 1 VIAL, SINGLE-DOSE |
ERTAPENEM SODIUM | ertapenem sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 209133 | ANDA | Eugia US LLC | 55150-282 | 55150-282-09 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-282-09) / 1 INJECTION in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Strength | EQ 1GM BASE/VIAL | ||||
Approval Date: | Jun 25, 2018 | TE: | AP | RLD: | No |
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