Details for New Drug Application (NDA): 212040
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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 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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