Assyro AI

Orange Book product · Generic (ANDA)

HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Generic (ANDA)ANDA 085457DISCN WATSON LABS

At a glance

Mar 04, 1982

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 04, 1982

    44 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Strength

25MG;25MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

ANDA 085457

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.