Assyro AI

Orange Book product · Generic (ANDA)

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE

ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE

Generic (ANDA)ANDA 076486DISCN MPP PHARMA

At a glance

Oct 27, 2004

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 27, 2004

    22 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE

Strength

5MG;12.5MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 076486

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE

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.