FDA Orange Book · active-ingredient family
Aztreonam
Aztreonam is approved as 3 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CAYSTON · NDA 050814
3
Brand (NDA)
4
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · for solution, injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CAYSTONRLD | GILEAD | NDA 050814 | — | Feb 22, 2010 | |
| AZACTAM IN PLASTIC CONTAINERRLD×3 | BRISTOL MYERS SQUIBB | NDA 050632 | — | May 24, 1989 | |
| AZACTAMRLD×3 | LABS DELBERT | NDA 050580 | AP | Dec 31, 1986 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AZTREONAM×2 | HIKMA | ANDA 207069 | — | Feb 05, 2026 | |
| AZTREONAM×2 | HOSPIRA | ANDA 206517 | AP | Nov 08, 2021 | |
| AZTREONAM×2 | HIKMA | ANDA 065286 | — | Mar 23, 2011 | |
| AZTREONAM×3 | FRESENIUS KABI USA | ANDA 065439 | AP | Jun 18, 2010 |
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.
Aztreonam — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
