Details for New Drug Application (NDA): 212040
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NDA 212040 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 212040
| Tradename: | ERTAPENEM SODIUM |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | ertapenem sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 212040
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ERTAPENEM SODIUM | ertapenem sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 212040 | ANDA | NorthStar RxLLC | 16714-889 | 16714-889-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (16714-889-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (16714-889-01) |
| ERTAPENEM SODIUM | ertapenem sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 212040 | ANDA | Dr.Reddys Laboratories Inc., | 43598-901 | 43598-901-58 | 10 VIAL, SINGLE-DOSE in 1 CARTON (43598-901-58) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (43598-901-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | Mar 26, 2021 | TE: | AP | RLD: | No | ||||
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