FDA Orange Book · active-ingredient family
Amlodipine besylate; hydrochlorothiazide; valsartan
Amlodipine besylate; hydrochlorothiazide; valsartan: 1 brand, 6 generics; first approved Apr 30, 2009; 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
35
Brand (NDA) products
Originator applications
- EXFORGE HCTRLDNOVARTISNDA 02231420095 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE;12.5MG;160MG TABLET ORAL Rx AB EQ 5MG BASE;25MG;160MG TABLET ORAL Rx AB EQ 10MG BASE;12.5MG;160MG TABLET ORAL Rx AB EQ 10MG BASE;25MG;160MG TABLET ORAL Rx AB EQ 10MG BASE;25MG;320MG TABLET ORAL Rx AB
Generic (ANDA) products (6)
Abbreviated applications
- MACLEODS PHARMSANDA 20729920255 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE;12.5MG;160MG TABLET ORAL Rx AB EQ 5MG BASE;25MG;160MG TABLET ORAL Rx AB EQ 10MG BASE;12.5MG;160MG TABLET ORAL Rx AB EQ 10MG BASE;25MG;160MG TABLET ORAL Rx AB EQ 10MG BASE;25MG;320MG TABLET ORAL Rx AB - AUROBINDO PHARMAANDA 20618020175 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE;12.5MG;160MG TABLET ORAL Rx AB EQ 5MG BASE;25MG;160MG TABLET ORAL Rx AB EQ 10MG BASE;12.5MG;160MG TABLET ORAL Rx AB EQ 10MG BASE;25MG;160MG TABLET ORAL Rx AB EQ 10MG BASE;25MG;320MG TABLET ORAL Rx AB - LUPINANDA 20079720155 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE;12.5MG;160MG TABLET ORAL Discontinued — EQ 5MG BASE;25MG;160MG TABLET ORAL Discontinued — EQ 10MG BASE;12.5MG;160MG TABLET ORAL Discontinued — EQ 10MG BASE;25MG;160MG TABLET ORAL Discontinued — EQ 10MG BASE;25MG;320MG TABLET ORAL Discontinued — - TORRENTANDA 20159320155 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE;12.5MG;160MG TABLET ORAL Discontinued — EQ 5MG BASE;25MG;160MG TABLET ORAL Discontinued — EQ 10MG BASE;12.5MG;160MG TABLET ORAL Discontinued — EQ 10MG BASE;25MG;160MG TABLET ORAL Discontinued — EQ 10MG BASE;25MG;320MG TABLET ORAL Discontinued — - STRIDES PHARMA INTLANDA 20108720155 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE;12.5MG;160MG TABLET ORAL Rx AB EQ 5MG BASE;25MG;160MG TABLET ORAL Rx AB EQ 10MG BASE;12.5MG;160MG TABLET ORAL Rx AB EQ 10MG BASE;25MG;160MG TABLET ORAL Rx AB EQ 10MG BASE;25MG;320MG TABLET ORAL Rx AB - TEVA PHARMSANDA 20043520125 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE;12.5MG;160MG TABLET ORAL Discontinued — EQ 5MG BASE;25MG;160MG TABLET ORAL Discontinued — EQ 10MG BASE;25MG;160MG TABLET ORAL Discontinued — EQ 10MG BASE;25MG;320MG TABLET ORAL Discontinued — EQ 10MG BASE;12.5MG;160MG 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
17 yr 8 mo ago
Most recent approval
1 yr 9 mo ago
Approvals span 2009–2025 across 7 FDA applications.
Brand (NDA) 114%
Generic (ANDA) 686%
Amlodipine besylate; hydrochlorothiazide; valsartan: 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.
