Orange Book product · Brand (NDA)

CONSENSI

AMLODIPINE BESYLATE; CELECOXIB

Brand (NDA)NDA 210045DISCN PURPLE BIOTECH

May 31, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 31, 2018
8 yr 2 mo ago
Today
Patent 10350171 expires
Listed drug product patent expiration.
Jun 14, 2038
in 12 yr 2 mo

Active ingredient

AMLODIPINE BESYLATE; CELECOXIB

Strength

EQ 2.5MG BASE;200MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 210045

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
10350171	Jun 14, 2038	in 12 yr 2 mo	Product