FDA Orange Book · active-ingredient family
Ceftazidime
Ceftazidime is approved as 3 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CEFTAZIDIME IN DEXTROSE CONTAINER · NDA 050823
3
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CEFTAZIDIME IN DEXTROSE CONTAINERRLD×2 | B BRAUN | NDA 050823 | — | Jun 13, 2011 | |
| FORTAZRLD×4 | PAI HOLDINGS PHARM | NDA 050578 | — | Jul 19, 1985 | |
| CEPTAZ×4 | GLAXOSMITHKLINE | NDA 050646 | — | Sep 27, 1990 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CEFTAZIDIME×3 | AUROBINDO PHARMA LTD | ANDA 065481 | — | May 28, 2010 | |
| CEFTAZIDIME | AUROBINDO PHARMA LTD | ANDA 065482 | — | May 28, 2010 | |
| CEFTAZIDIME | WOCKHARDT | ANDA 065196 | — | Oct 15, 2008 | |
| PENTACEF×2 | GLAXOSMITHKLINE | ANDA 063322 | — | Nov 07, 1995 | |
| TAZICEF×2 | HOSPIRA | ANDA 064032 | AP | Oct 31, 1993 | |
| PENTACEF×2 | GLAXOSMITHKLINE | ANDA 064006 | — | Mar 31, 1992 | |
| PENTACEF×2 | GLAXOSMITHKLINE | ANDA 064008 | — | Mar 31, 1992 | |
| TAZIDIME IN PLASTIC CONTAINER×2 | LILLY | ANDA 062739 | — | Jul 10, 1986 | |
| TAZICEF×4 | HOSPIRA | ANDA 062662 | AP | Mar 06, 1986 | |
| CEFTAZIDIME×4 | ACS DOBFAR | ANDA 062640 | AP | Nov 20, 1985 | |
| TAZIDIME×2 | LILLY | ANDA 062655 | — | Nov 20, 1985 |
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.
Ceftazidime — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
