Details for New Drug Application (NDA): 218067
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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 218067
Tradename: | ERTAPENEM SODIUM |
Applicant: | Qilu |
Ingredient: | ertapenem sodium |
Patents: | 0 |
Suppliers and Packaging for NDA: 218067
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ERTAPENEM SODIUM | ertapenem sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 218067 | ANDA | Qilu Pharmaceutical Co., Ltd. | 67184-0551 | 67184-0551-2 | 10 VIAL, SINGLE-DOSE in 1 CARTON (67184-0551-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (67184-0551-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Strength | EQ 1GM BASE/VIAL | ||||
Approval Date: | Oct 31, 2024 | TE: | AP | RLD: | No |
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