FDA Orange Book · active-ingredient family
Ceftizoxime sodium
Ceftizoxime sodium is approved as 2 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER · NDA 050589
2
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER×4 | ASTELLAS | NDA 050589 | — | Oct 03, 1984 | |
| CEFIZOX×4 | ASTELLAS | NDA 050560 | — | Sep 15, 1983 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CEFIZOX×2 | ASTELLAS | ANDA 063294 | — | Mar 31, 1994 |
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.
Ceftizoxime sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
