Assyro AI

Orange Book product · Brand (NDA)

VASOTEC

ENALAPRIL MALEATE

Brand (NDA)NDA 018998TE ABRX BAUSCH
View ENALAPRIL MALEATE familyOpen on FDA Orange Book

At a glance

Jul 26, 1988

Approved

Brand (NDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 26, 1988

    38 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ENALAPRIL MALEATE

Strength

2.5MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

NDA 018998

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.

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