Methazolamide
Methazolamide: 1 brand, 8 generics; first approved Nov 25, 1991; generic available.
Generic available: 8 ANDA applications approved.
Brand (NDA) products
- NEPTAZANERLDLEDERLENDA 01172119912 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued —
Generic (ANDA) products (8)
- METHAZOLAMIDEAJANTA PHARMA LTDANDA 21740820262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB - METHAZOLAMIDETAGIANDA 21561520222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB - METHAZOLAMIDEBAUSCH AND LOMB INCANDA 20743820182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB - METHAZOLAMIDEAPPLIED ANALANDA 04001119972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — - METHAZOLAMIDEPOM PHARMAANDA 04010219962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — - METHAZOLAMIDEANDA REPOSITORYANDA 04006219942 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB - METHAZOLAMIDEANI PHARMSANDA 04000119932 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB - METHAZOLAMIDECHARTWELL RXANDA 04003619932 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB
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.
Approval history
Approvals span 1991–2026 across 9 FDA applications.
Methazolamide: 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.

Go beyond the database.
Try Assyro Intelligence for your regulatory research. Ready to discuss your team’s workflow? Book a demo.
