FDA Orange Book · active-ingredient family
Methyclothiazide
Methyclothiazide: 2 brands, 13 generics; first approved Mar 11, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 13 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
13
Listed patents
0
Presentations
16
Brand (NDA) products
Originator applications
- ENDURONRLDABBVIENDA 012524—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — - MEDPOINTE PHARM HLCNDA 017364—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued —
Generic (ANDA) products (13)
Abbreviated applications
- METHYCLOTHIAZIDECHARTWELL RXANDA 0898351988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — - METHYCLOTHIAZIDECHARTWELL RXANDA 0898371988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - METHYCLOTHIAZIDEPAR PHARMANDA 0891351986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — - METHYCLOTHIAZIDEPAR PHARMANDA 0891361986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - METHYCLOTHIAZIDEUSL PHARMAANDA 0887451985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - METHYCLOTHIAZIDEWATSON LABSANDA 0887501984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — - METHYCLOTHIAZIDEWATSON LABSANDA 0887241984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - METHYCLOTHIAZIDEMYLANANDA 0876711982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — - METHYCLOTHIAZIDEPHARMOBEDIENTANDA 0876721982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - METHYCLOTHIAZIDEIVAX PHARMSANDA 0879131982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — - METHYCLOTHIAZIDEIVAX PHARMSANDA 0877861982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - METHYCLOTHIAZIDEWATSON LABSANDA 0854871982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — - METHYCLOTHIAZIDEWATSON LABSANDA 0854761982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued —
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
45 yr 3 mo ago
Most recent approval
38 yr 8 mo ago
Approvals span 1982–1988 across 15 FDA applications.
Brand (NDA) 213%
Generic (ANDA) 1387%
Methyclothiazide: 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.
