Orange Book product · Brand (NDA)

TEKTURNA HCT

ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE

Brand (NDA)NDA 022107DISCN NODEN PHARMA

Jan 18, 2008

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 18, 2008
18 yr 8 mo ago
Today
Patent 8618172 expires
Listed drug product patent expiration.
Jul 13, 2028
in 2 yr 1 mo

Active ingredient

ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE

Strength

EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 022107

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8618172	Jul 13, 2028	in 2 yr 1 mo	Product