Details for New Drug Application (NDA): 091031
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NDA 091031 describes CEFOTETAN, which is a drug marketed by Fresenius Kabi Usa, Hikma, West-ward Pharm Corp, and B Braun, and is included in five NDAs. It is available from two suppliers. Additional details are available on the CEFOTETAN profile page.
The generic ingredient in CEFOTETAN is cefotetan disodium. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cefotetan disodium profile page.
The generic ingredient in CEFOTETAN is cefotetan disodium. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cefotetan disodium profile page.
Summary for 091031
| Tradename: | CEFOTETAN |
| Applicant: | Hikma |
| Ingredient: | cefotetan disodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091031
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFOTETAN | cefotetan disodium | INJECTABLE;INJECTION | 091031 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9670 | 0143-9670-10 | 10 VIAL in 1 CARTON (0143-9670-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9670-01) |
| CEFOTETAN | cefotetan disodium | INJECTABLE;INJECTION | 091031 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9671 | 0143-9671-10 | 10 VIAL in 1 CARTON (0143-9671-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9671-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | Oct 26, 2011 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2GM BASE/VIAL | ||||
| Approval Date: | Oct 26, 2011 | TE: | RLD: | No | |||||
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