FDA Orange Book · active-ingredient family
Acetazolamide
Acetazolamide is approved as 2 brand and 31 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DIAMOX · NDA 012945
2
Brand (NDA)
31
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, extended release, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DIAMOXRLD | TEVA BRANDED PHARM | NDA 012945 | — | Approved Prior to Jan 1, 1982 | |
| DIAMOXRLD×2 | TEVA BRANDED PHARM | NDA 008943 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (31)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ACETAZOLAMIDE×2 | AUROBINDO PHARMA LTD | ANDA 212089 | AB | May 30, 2025 | |
| ACETAZOLAMIDE×2 | EPIC PHARMA LLC | ANDA 218023 | AB | May 14, 2024 | |
| ACETAZOLAMIDE×2 | TORRENT | ANDA 213706 | — | Jan 26, 2024 | |
| ACETAZOLAMIDE×2 | AJANTA PHARMA LTD | ANDA 211151 | — | Sep 11, 2023 | |
| ACETAZOLAMIDE×2 | NE RX PHARMA | ANDA 217197 | AB | May 09, 2023 | |
| ACETAZOLAMIDE×2 | ZYDUS LIFESCIENCES | ANDA 211069 | AB | Apr 04, 2023 | |
| ACETAZOLAMIDE×2 | RUBICON RESEARCH | ANDA 215101 | AB | Aug 19, 2021 | |
| ACETAZOLAMIDE×2 | SOMERSET THERAPS LLC | ANDA 211372 | AB | Feb 22, 2021 | |
| ACETAZOLAMIDE×2 | MANKIND PHARMA | ANDA 214282 | AB | Oct 07, 2020 | |
| ACETAZOLAMIDE | MICRO LABS LTD INDIA | ANDA 207401 | AB | Oct 01, 2020 | |
| ACETAZOLAMIDE×2 | BRECKENRIDGE | ANDA 207503 | — | Apr 30, 2020 | |
| ACETAZOLAMIDE×2 | HIBROW HLTHCARE | ANDA 211556 | AB | Oct 18, 2019 | |
| ACETAZOLAMIDE×2 | NOVITIUM PHARMA | ANDA 210588 | AB | Oct 17, 2019 | |
| ACETAZOLAMIDE | RISING | ANDA 203917 | — | Jun 18, 2019 | |
| ACETAZOLAMIDE | ALEMBIC | ANDA 210423 | AB | Feb 19, 2019 | |
| ACETAZOLAMIDE | CADILA | ANDA 205301 | AB | Jan 16, 2019 | |
| ACETAZOLAMIDE | ACCORD HLTHCARE | ANDA 207659 | AB | Oct 18, 2018 | |
| ACETAZOLAMIDE×2 | STRIDES PHARMA | ANDA 209734 | AB | Nov 20, 2017 | |
| ACETAZOLAMIDE×2 | HERITAGE PHARMA | ANDA 205530 | AB | Oct 27, 2016 | |
| ACETAZOLAMIDE | NOVAST LABS | ANDA 203434 | AB | Sep 30, 2016 | |
| ACETAZOLAMIDE | MPP PHARMA | ANDA 204691 | AB | Mar 29, 2016 | |
| ACETAZOLAMIDE | INDICUS PHARMA | ANDA 090779 | AB | Jul 14, 2011 | |
| ACETAZOLAMIDE | HERITAGE PHARMA | ANDA 040904 | AB | Dec 10, 2008 | |
| ACETAZOLAMIDE×2 | TARO | ANDA 040195 | AB | May 28, 1997 | |
| ACETAZOLAMIDE×2 | SUN PHARM INDUSTRIES | ANDA 089753 | — | Jun 22, 1988 | |
| ACETAZOLAMIDE | HERITAGE PHARMA | ANDA 088882 | — | Oct 22, 1985 | |
| ACETAZOLAMIDE | ASCOT | ANDA 087686 | — | Oct 20, 1982 | |
| ACETAZOLAMIDE | VANGARD | ANDA 087654 | — | Feb 05, 1982 | |
| ACETAZOLAMIDE | ALRA | ANDA 083320 | — | Approved Prior to Jan 1, 1982 | |
| ACETAZOLAMIDE | CHARTWELL MOLECULAR | ANDA 084840 | AB | Approved Prior to Jan 1, 1982 | |
| ACETAZOLAMIDE | WATSON LABS | ANDA 084498 | — | Approved Prior to Jan 1, 1982 |
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 — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
