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FDA Orange Book · active-ingredient family

Hydrochlorothiazide; pindolol

Hydrochlorothiazide; pindolol: 1 brand, 0 generics; first approved Jul 22, 1987.

Brand onlyHas discontinued products
Generic status & protection

No listed patents or exclusivity: brand product(s) only.

Brands (NDA)
1
Generics (ANDA)
0
Listed patents
0
Presentations
2

Brand (NDA) products

Originator applications
  • NDA 01887219872 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25MG;5MGTABLETORALDiscontinued
    25MG;10MGTABLETORALDiscontinued

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
39 yr 7 mo ago
Most recent approval
39 yr 7 mo ago

All 1 application were approved in 1987.

Brand (NDA) 1100%
Generic (ANDA) 00%

Hydrochlorothiazide; pindolol: 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

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