Application 065374
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CEFOTETAN | CEFOTETAN DISODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | Yes |
| 002 | CEFOTETAN | CEFOTETAN DISODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-385 | Cefotetan | CEFOTETAN DISODIUM | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-385 | Cefotetan | CEFOTETAN DISODIUM | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-385 | Cefotetan | CEFOTETAN DISODIUM | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-386 | Cefotetan | CEFOTETAN DISODIUM | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-386 | Cefotetan | CEFOTETAN DISODIUM | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-386 | Cefotetan | CEFOTETAN DISODIUM | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 8394 | ORIG | 2007-08-14 |