Details for New Drug Application (NDA): 208790
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NDA 208790 describes ERTAPENEM SODIUM, which is a drug marketed by Acs Dobfar Spa, Eugia Pharma, Gland Pharma Ltd, Savior Lifetec Corp, and Sun Pharm, and is included in five NDAs. It is available from twelve 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. Fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the ertapenem sodium profile page.
Summary for 208790
| Tradename: | ERTAPENEM SODIUM |
| Applicant: | Acs Dobfar Spa |
| Ingredient: | ertapenem sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 208790
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ERTAPENEM SODIUM | ertapenem sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 208790 | ANDA | Hikma Pharmaceuticals USA, Inc. | 0143-9398 | 0143-9398-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9398-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0143-9398-01) |
| ERTAPENEM SODIUM | ertapenem sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 208790 | ANDA | Hospira, Inc. | 0409-3510 | 0409-3510-22 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-3510-22) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-3510-21) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | Apr 16, 2018 | TE: | AP | RLD: | No | ||||
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