FDA Orange Book · active-ingredient family
Hydralazine hydrochloride; hydrochlorothiazide; reserpine
Hydralazine hydrochloride; hydrochlorothiazide; reserpine: 1 brand, 15 generics; first approved May 13, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 15 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
15
Listed patents
0
Presentations
16
Brand (NDA) products
Originator applications
- NOVARTISNDA 012193—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;15MG;0.1MG TABLET ORAL Discontinued —
Generic (ANDA) products (15)
Abbreviated applications
- SUN PHARM INDUSTRIESANDA 0885701984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;15MG;0.1MG TABLET ORAL Discontinued — - SOLVAYANDA 0883761983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;15MG;0.1MG TABLET ORAL Discontinued — - LEDERLEANDA 0877091982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;15MG;0.1MG TABLET ORAL Discontinued — - CHARTWELL RXANDA 084897—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;15MG;0.1MG TABLET ORAL Discontinued — - IVAX SUB TEVA PHARMSANDA 084291—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;15MG;0.1MG TABLET ORAL Discontinued — - HYDRALAZINE HYDROCHLORIDE-HYDROCHLOROTHIAZIDE-RESERPINEMYLANANDA 087085—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;15MG;0.1MG TABLET ORAL Discontinued — - WATSON LABSANDA 085771—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;15MG;0.1MG TABLET ORAL Discontinued — - SANDOZANDA 084876—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;15MG;0.1MG TABLET ORAL Discontinued — - WATSON LABSANDA 083770—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;15MG;0.1MG TABLET ORAL Discontinued — - IVAX SUB TEVA PHARMSANDA 083877—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;15MG;0.1MG TABLET ORAL Discontinued — - WATSON LABSANDA 085549—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;15MG;0.1MG TABLET ORAL Discontinued — - WATSON LABSANDA 087556—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;15MG;0.1MG TABLET ORAL Discontinued — - SOLVAYANDA 087210—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;15MG;0.1MG TABLET ORAL Discontinued — - SOLVAYANDA 085893—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;15MG;0.1MG TABLET ORAL Discontinued — - SOLVAYANDA 086298—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG;15MG;0.1MG 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 1 mo ago
Most recent approval
43 yr 1 mo ago
Approvals span 1982–1984 across 16 FDA applications.
Brand (NDA) 16%
Generic (ANDA) 1594%
Hydralazine hydrochloride; hydrochlorothiazide; 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.
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