Amturnide
Aliskiren Hemifumarate; Amlodipine Besylate; Hydrochlorothiazide
Sourced from the FDA Orange Book
Key dates
Key dates
Approval
FDA approval date of this drug product.
Dec 21, 2010
15 yr 9 mo ago
Today
Pharmaceutical detail
Pharmaceutical detail
Active ingredient
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE
Strength
EQ 300MG BASE;EQ 5MG BASE;25MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 200045
Product number
003
Marketing status
Discontinued
Reference listed drug (RLD)
No
Reference standard (RS)
No
Other strengths in NDA 200045
Active-ingredient family
This is a brand (NDA) product. Other products sharing this active ingredient are listed below.
No other applications share this active ingredient.
View full Aliskiren Hemifumarate; Amlodipine Besylate; Hydrochlorothiazide familyListed patents
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.
Amturnide — frequently asked questions
Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.
Built directly from the FDA Orange Book data file. This product page links back to the Aliskiren Hemifumarate; Amlodipine Besylate; Hydrochlorothiazide active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
