Hydroflumethiazide; reserpine
Hydroflumethiazide; reserpine: 1 brand, 5 generics; first approved Mar 22, 1983; generic available.
Generic available: 5 ANDA applications approved.
Brand (NDA) products
- SHIRENDA 012359-2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG;0.125MG TABLET ORAL Discontinued - 25MG;0.125MG TABLET ORAL Discontinued -
Generic (ANDA) products (5)
- PAR PHARMANDA 0889071985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG;0.125MG TABLET ORAL Discontinued - - IVAX PHARMSANDA 0889321985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG;0.125MG TABLET ORAL Discontinued - - USL PHARMAANDA 0881951983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG;0.125MG TABLET ORAL Discontinued - - WATSON LABSANDA 0881271983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;0.125MG TABLET ORAL Discontinued - - WATSON LABSANDA 0881101983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG;0.125MG TABLET ORAL Discontinued -
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 1983–1985 across 6 FDA applications.
Hydroflumethiazide; reserpine: 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.
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