Details for New Drug Application (NDA): 065374
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NDA 065374 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 065374
| Tradename: | CEFOTETAN |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | cefotetan disodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065374
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFOTETAN | cefotetan disodium | INJECTABLE;INJECTION | 065374 | ANDA | Fresenius Kabi USA, LLC | 63323-385 | 63323-385-10 | 10 VIAL in 1 CARTON (63323-385-10) / 10 mL in 1 VIAL (63323-385-01) |
| CEFOTETAN | cefotetan disodium | INJECTABLE;INJECTION | 065374 | ANDA | Fresenius Kabi USA, LLC | 63323-386 | 63323-386-20 | 10 VIAL in 1 CARTON (63323-386-20) / 20 mL in 1 VIAL (63323-386-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | Aug 9, 2007 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2GM BASE/VIAL | ||||
| Approval Date: | Aug 9, 2007 | TE: | AP | RLD: | No | ||||
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