Details for New Drug Application (NDA): 091117
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NDA 091117 describes CEFTRIAXONE SODIUM, which is a drug marketed by Anda Repository and Hikma and is included in two NDAs. It is available from two suppliers. Additional details are available on the CEFTRIAXONE SODIUM profile page.
The generic ingredient in CEFTRIAXONE SODIUM is ceftriaxone sodium. There are twenty-six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the ceftriaxone sodium profile page.
The generic ingredient in CEFTRIAXONE SODIUM is ceftriaxone sodium. There are twenty-six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the ceftriaxone sodium profile page.
Summary for 091117
| Tradename: | CEFTRIAXONE SODIUM |
| Applicant: | Anda Repository |
| Ingredient: | ceftriaxone sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091117
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFTRIAXONE SODIUM | ceftriaxone sodium | INJECTABLE;INJECTION | 091117 | ANDA | Xellia Pharmaceuticals USA LLC | 70594-098 | 70594-098-01 | 1 VIAL in 1 CARTON (70594-098-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10GM BASE/VIAL | ||||
| Approval Date: | Jan 20, 2017 | TE: | AP | RLD: | No | ||||
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