FDA Orange Book · active-ingredient family
Cefotetan disodium
Cefotetan disodium is approved as 3 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER · NDA 065430
3
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINERRLD×2 | B BRAUN | NDA 065430 | — | Aug 09, 2007 | |
| CEFOTANRLD×3 | PAI HOLDINGS PHARM | NDA 050588 | AP | Dec 27, 1985 | |
| CEFOTAN IN PLASTIC CONTAINER×2 | PAI HOLDINGS PHARM | NDA 050694 | — | Jul 30, 1993 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CEFOTETAN×2 | HIKMA | ANDA 091031 | — | Oct 26, 2011 | |
| CEFOTETAN | WEST-WARD PHARM CORP | ANDA 091030 | — | Oct 26, 2011 | |
| CEFOTETAN×2 | FRESENIUS KABI USA | ANDA 065374 | AP | Aug 09, 2007 | |
| CEFOTETAN | FRESENIUS KABI USA | ANDA 065375 | — | Aug 09, 2007 | |
| CEFOTAN×2 | TELIGENT | ANDA 063293 | — | Apr 29, 1993 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Cefotetan disodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
