Details for New Drug Application (NDA): 209133
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NDA 209133 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.
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 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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