Orange Book product · Brand (NDA)

LOTREL

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Brand (NDA)NDA 020364DISCN SANDOZ

View AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE family Open on FDA Orange Book

At a glance

Apr 11, 2006

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Apr 11, 2006
20 yr 6 mo ago
Today

Pharmaceutical detail

Active ingredient

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Strength

EQ 5MG BASE;40MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 020364

Product number

007

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

View full family

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

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.

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