FDA Orange Book · active-ingredient family
Chlorothiazide; reserpine
Chlorothiazide; reserpine: 1 brand, 6 generics; first approved May 06, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 6 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
6
Listed patents
0
Presentations
8
Brand (NDA) products
Originator applications
- MERCKNDA 01163519872 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG;0.125MG TABLET ORAL Discontinued — 500MG;0.125MG TABLET ORAL Discontinued —
Generic (ANDA) products (6)
Abbreviated applications
- HIKMAANDA 0885571983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG;0.125MG TABLET ORAL Discontinued — - HIKMAANDA 0883651983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG;0.125MG TABLET ORAL Discontinued — - WATSON LABSANDA 0881511983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG;0.125MG TABLET ORAL Discontinued — - CHLOROTHIAZIDE-RESERPINEPHARMOBEDIENTANDA 0877441982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG;0.125MG TABLET ORAL Discontinued — - CHLOROTHIAZIDE-RESERPINEPHARMOBEDIENTANDA 0877451982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG;0.125MG TABLET ORAL Discontinued — - WATSON LABSANDA 084853—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG;0.125MG 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 11 mo ago
Most recent approval
39 yr 7 mo ago
Approvals span 1982–1987 across 7 FDA applications.
Brand (NDA) 114%
Generic (ANDA) 686%
Chlorothiazide; 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
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