Details for New Drug Application (NDA): 091049
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The generic ingredient in CEFTRIAXONE 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 091049
Tradename: | CEFTRIAXONE |
Applicant: | Astral |
Ingredient: | ceftriaxone sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 091049
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CEFTRIAXONE | ceftriaxone sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 091049 | ANDA | Xellia Pharmaceuticals USA LLC | 70594-094 | 70594-094-02 | 25 VIAL in 1 CARTON (70594-094-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-094-01) |
CEFTRIAXONE | ceftriaxone sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 091049 | ANDA | Xellia Pharmaceuticals USA LLC | 70594-095 | 70594-095-02 | 25 VIAL in 1 CARTON (70594-095-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-095-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Strength | EQ 250MG BASE/VIAL | ||||
Approval Date: | Jun 11, 2018 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Strength | EQ 500MG BASE/VIAL | ||||
Approval Date: | Jun 11, 2018 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Strength | EQ 1GM BASE/VIAL | ||||
Approval Date: | Jun 11, 2018 | TE: | AP | RLD: | No |
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