Assyro AI

Orange Book product · Generic (ANDA)

HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 100/50

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Generic (ANDA)ANDA 088358DISCN IVAX PHARMS

At a glance

Apr 10, 1984

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 10, 1984

    42 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Strength

100MG;50MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

ANDA 088358

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of HYDRALAZINE HYDROCHLORIDE; 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.