Aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
Aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide: 1 brand, 0 generics; first approved Dec 21, 2010.
No listed patents or exclusivity: brand product(s) only.
Brand (NDA) products
- NOVARTISNDA 20004520105 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE;EQ 5MG BASE;12.5MG TABLET ORAL Discontinued — EQ 300MG BASE;EQ 5MG BASE;12.5MG TABLET ORAL Discontinued — EQ 300MG BASE;EQ 5MG BASE;25MG TABLET ORAL Discontinued — EQ 300MG BASE;EQ 10MG BASE;12.5MG TABLET ORAL Discontinued — EQ 300MG BASE;EQ 10MG BASE;25MG 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
All 1 application were approved in 2010.
Aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide: 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.
