Composition
- Active ingredients
- ALISKIREN HEMIFUMARATE EQ 300MG BASE; HYDROCHLOROTHIAZIDE 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- ALISKIREN HEMIFUMARATE EQ 300MG BASE; HYDROCHLOROTHIAZIDE 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletThis page
- ALISKIREN HEMIFUMARATE EQ 150MG BASE; HYDROCHLOROTHIAZIDE 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA022107-001 · Discontinued
- ALISKIREN HEMIFUMARATE EQ 300MG BASE; HYDROCHLOROTHIAZIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA022107-004 · Discontinued
- ALISKIREN HEMIFUMARATE EQ 150MG BASE; HYDROCHLOROTHIAZIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA022107-002 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA022107.
At a glance
- Brand name
- Tekturna HCT
- Active substance
- aliskiren hemifumarate
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Noden Pharma
- Status
- Discontinued
- FDA approval
- 18 Jan 2008
- Application
- NDA022107-003