FDA Orange Book · active-ingredient family
Cefuroxime sodium
Cefuroxime sodium is approved as 3 brand and 17 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER · NDA 050780
3
Brand (NDA)
17
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINERRLD×2 | B BRAUN | NDA 050780 | — | Feb 21, 2001 | |
| ZINACEF IN PLASTIC CONTAINERRLD×2 | PAI HOLDINGS PHARM | NDA 050643 | — | Apr 28, 1989 | |
| ZINACEFRLD×3 | PAI HOLDINGS PHARM | NDA 050558 | — | Oct 19, 1983 |
Generic (ANDA) products (17)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CEFUROXIME SODIUM IN PLASTIC CONTAINER×2 | SAMSON MEDCL | ANDA 065251 | — | Dec 30, 2009 | |
| CEFUROXIME SODIUM×2 | HOSPIRA INC | ANDA 065483 | — | Oct 15, 2008 | |
| CEFUROXIME SODIUM | HOSPIRA INC | ANDA 065503 | — | Oct 15, 2008 | |
| CEFUROXIME SODIUM | HOSPIRA INC | ANDA 065484 | — | Oct 15, 2008 | |
| CEFUROXIME SODIUM×2 | HIKMA | ANDA 065048 | AP | Jan 09, 2004 | |
| CEFUROXIME SODIUM | HIKMA | ANDA 065046 | — | Jan 09, 2004 | |
| CEFUROXIME SODIUM×2 | FRESENIUS KABI USA | ANDA 065001 | — | May 30, 2001 | |
| CEFUROXIME SODIUM | FRESENIUS KABI USA | ANDA 065002 | — | Sep 28, 1998 | |
| CEFUROXIME SODIUM | TEVA PHARMS | ANDA 064191 | — | Apr 16, 1998 | |
| CEFUROXIME SODIUM×2 | TEVA PHARMS | ANDA 064192 | — | Apr 16, 1998 | |
| CEFUROXIME SODIUM×2 | ACS DOBFAR SPA | ANDA 064125 | AP | May 30, 1997 | |
| CEFUROXIME SODIUM | ACS DOBFAR SPA | ANDA 064124 | — | May 30, 1997 | |
| CEFUROXIME SODIUM×2 | WATSON LABS INC | ANDA 064035 | — | Feb 26, 1993 | |
| CEFUROXIME SODIUM | WATSON LABS INC | ANDA 064036 | — | Feb 26, 1993 | |
| KEFUROX×3 | ACS DOBFAR | ANDA 062591 | — | Jan 10, 1986 | |
| KEFUROX×2 | LILLY | ANDA 062592 | — | Jan 10, 1986 | |
| KEFUROX IN PLASTIC CONTAINER×2 | LILLY | ANDA 062590 | — | Jan 10, 1986 |
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.
Cefuroxime sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
