Orange Book product · Brand (NDA)

PRESTALIA

AMLODIPINE BESYLATE; PERINDOPRIL ARGININE

Brand (NDA)NDA 205003DISCN ADHERA

Jan 21, 2015

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 21, 2015
11 yr 7 mo ago
Today
Patent 7846961 expires
Listed drug substance patent expiration.
Oct 05, 2029
in 3 yr 4 mo

Active ingredient

AMLODIPINE BESYLATE; PERINDOPRIL ARGININE

Strength

EQ 2.5MG BASE;3.5MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 205003

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
7846961	Oct 05, 2029	in 3 yr 4 mo	SubstanceProductU-3