Assyro AI

Orange Book product · Brand (NDA)

ZESTRIL

LISINOPRIL

Brand (NDA)NDA 019777TE ABRX TWI PHARMS

At a glance

Apr 29, 1993

Approved

Brand (NDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 29, 1993

    33 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

LISINOPRIL

Strength

2.5MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

NDA 019777

Product number

005

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.