Assyro AI

Orange Book product · Generic (ANDA)

HYDRALAZINE HYDROCHLORIDE

HYDRALAZINE HYDROCHLORIDE

Generic (ANDA)ANDA 089098TE AARX PLIVA

At a glance

Dec 18, 1985

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 18, 1985

    41 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HYDRALAZINE HYDROCHLORIDE

Strength

100MG

Dosage form

TABLET

Route

ORAL

TE code

AA

Application

ANDA 089098

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of HYDRALAZINE HYDROCHLORIDE

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.