Details for New Drug Application (NDA): 065072
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NDA 065072 describes CEFOTAXIME, which is a drug marketed by Fresenius Kabi Usa, Hikma, Wockhardt, B Braun, Aurobindo Pharma, Aurobindo Pharma Ltd, Cephazone Pharma, Hospira, Hospira Inc, and Lupin, and is included in fourteen NDAs. It is available from one supplier. Additional details are available on the CEFOTAXIME profile page.
The generic ingredient in CEFOTAXIME is cefotaxime sodium. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cefotaxime sodium profile page.
The generic ingredient in CEFOTAXIME is cefotaxime sodium. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cefotaxime sodium profile page.
Summary for 065072
| Tradename: | CEFOTAXIME |
| Applicant: | Hikma |
| Ingredient: | cefotaxime sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065072
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFOTAXIME | cefotaxime sodium | INJECTABLE;INJECTION | 065072 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9930 | 0143-9930-10 | 10 VIAL in 1 PACKAGE (0143-9930-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9930-01) |
| CEFOTAXIME | cefotaxime sodium | INJECTABLE;INJECTION | 065072 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9931 | 0143-9931-25 | 25 VIAL in 1 PACKAGE (0143-9931-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9931-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | Nov 20, 2002 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | Nov 20, 2002 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2GM BASE/VIAL | ||||
| Approval Date: | Nov 20, 2002 | TE: | RLD: | No | |||||
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