FDA Orange Book · active-ingredient family
Acetazolamide sodium
Acetazolamide sodium: 1 brand, 8 generics; first approved Feb 28, 1995; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 8 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
8
Listed patents
0
Presentations
9
Brand (NDA) products
Originator applications
- DIAMOXRLDTEVA WOMENSNDA 009388—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (8)
Abbreviated applications
- ACETAZOLAMIDE SODIUMGLANDANDA 2197752025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - ACETAZOLAMIDE SODIUMZYDUS PHARMSANDA 2065332019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - ACETAZOLAMIDE SODIUMPH HEALTHANDA 2053582017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — - ACETAZOLAMIDE SODIUMAVET LIFESCIENCESANDA 2026932014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - ACETAZOLAMIDE SODIUMMYLAN ASIANDA 2008802012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - ACETAZOLAMIDE SODIUMRSXGEN PHARMSANDA 0407842008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - ACETAZOLAMIDE SODIUMHOSPIRAANDA 0401081995
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — - ACETAZOLAMIDE SODIUMHIKMAANDA 0400891995
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
31 yr 11 mo ago
Most recent approval
1 yr 3 mo ago
Approvals span 1995–2025 across 9 FDA applications.
Brand (NDA) 111%
Generic (ANDA) 889%
Acetazolamide sodium: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
