FDA Orange Book · active-ingredient family
Acetazolamide sodium
Acetazolamide sodium is approved as 1 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DIAMOX · NDA 009388
1
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DIAMOXRLD | TEVA WOMENS | NDA 009388 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ACETAZOLAMIDE SODIUM | GLAND | ANDA 219775 | AP | Jun 17, 2025 | |
| ACETAZOLAMIDE SODIUM | ZYDUS PHARMS | ANDA 206533 | AP | Apr 15, 2019 | |
| ACETAZOLAMIDE SODIUM | PH HEALTH | ANDA 205358 | — | Jun 20, 2017 | |
| ACETAZOLAMIDE SODIUM | AVET LIFESCIENCES | ANDA 202693 | AP | Dec 19, 2014 | |
| ACETAZOLAMIDE SODIUM | MYLAN ASI | ANDA 200880 | AP | May 09, 2012 | |
| ACETAZOLAMIDE SODIUM | XGEN PHARMS | ANDA 040784 | AP | Dec 10, 2008 | |
| ACETAZOLAMIDE SODIUM | HOSPIRA | ANDA 040108 | — | Oct 30, 1995 | |
| ACETAZOLAMIDE SODIUM | HIKMA | ANDA 040089 | AP | Feb 28, 1995 |
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.
Acetazolamide sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
