Details for New Drug Application (NDA): 065238
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NDA 065238 describes CEFOXITIN, which is a drug marketed by Acs Dobfar, Acs Dobfar Spa, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Hospira Inc, B Braun, and Samson Medcl, and is included in fourteen NDAs. It is available from four suppliers. Additional details are available on the CEFOXITIN profile page.
The generic ingredient in CEFOXITIN is cefoxitin sodium. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the cefoxitin sodium profile page.
The generic ingredient in CEFOXITIN is cefoxitin sodium. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the cefoxitin sodium profile page.
Summary for 065238
| Tradename: | CEFOXITIN |
| Applicant: | Hikma Farmaceutica |
| Ingredient: | cefoxitin sodium |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 065238
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFOXITIN | cefoxitin sodium | INJECTABLE;INJECTION | 065238 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9877 | 0143-9877-25 | 25 VIAL in 1 CARTON (0143-9877-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9877-01) |
| CEFOXITIN | cefoxitin sodium | INJECTABLE;INJECTION | 065238 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9878 | 0143-9878-25 | 25 VIAL in 1 CARTON (0143-9878-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9878-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | Mar 12, 2010 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2GM BASE/VIAL | ||||
| Approval Date: | Mar 12, 2010 | TE: | AP | RLD: | No | ||||
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