FDA Orange Book · active-ingredient family
Chlorothiazide
Chlorothiazide: 2 brands, 12 generics; first approved Jul 14, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 12 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
12
Listed patents
0
Presentations
16
Brand (NDA) products
Originator applications
- DIURILRLDSALIX PHARMSNDA 011870—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML SUSPENSION ORAL Discontinued — - DIURILRLDRISINGNDA 011145—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 250MG TABLET ORAL Discontinued —
Generic (ANDA) products (12)
Abbreviated applications
- CHLOROTHIAZIDEWATSON LABSANDA 0867951983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — - CHLOROTHIAZIDEWATSON LABSANDA 0867961983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — - CHLOROTHIAZIDEWATSON LABSANDA 0840261982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — - CHLOROTHIAZIDEHIKMA INTL PHARMSANDA 0860281982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — - CHLOROTHIAZIDEHIKMA INTL PHARMSANDA 0877361982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — - CHLOROTHIAZIDEABC HOLDINGANDA 085569—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — - CHLOROTHIAZIDELEDERLEANDA 086940—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — - CHLOROTHIAZIDELEDERLEANDA 086938—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — - CHLOROTHIAZIDEPHARMOBEDIENTANDA 084217—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 250MG TABLET ORAL Discontinued — - CHLOROTHIAZIDESANDOZANDA 085485—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — - CHLOROTHIAZIDEWATSON LABSANDA 085165—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — - CHLOROTHIAZIDEWATSON LABSANDA 085173—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG 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
44 yr 9 mo ago
Most recent approval
43 yr 8 mo ago
Approvals span 1982–1983 across 14 FDA applications.
Brand (NDA) 214%
Generic (ANDA) 1286%
Chlorothiazide: 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.
