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Details for New Drug Application (NDA): 065517
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NDA 065517 describes CEFOTAXIME SODIUM, which is a drug marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, Cephazone Pharma, Hospira Inc, Lupin, and Wockhardt, and is included in nine NDAs. It is available from one supplier. Additional details are available on the CEFOTAXIME SODIUM profile page.
The generic ingredient in CEFOTAXIME SODIUM is cefotaxime sodium. There are fourteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cefotaxime sodium profile page.
The generic ingredient in CEFOTAXIME SODIUM is cefotaxime sodium. There are fourteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cefotaxime sodium profile page.
Summary for 065517
| Tradename: | CEFOTAXIME SODIUM |
| Applicant: | Aurobindo Pharma |
| Ingredient: | cefotaxime sodium |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 065517
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | Nov 6, 2009 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | Nov 6, 2009 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2GM BASE/VIAL | ||||
| Approval Date: | Nov 6, 2009 | TE: | RLD: | No | |||||
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