Details for New Drug Application (NDA): 065238
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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 |
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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