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Orange Book product · Generic (ANDA)

HYDRALAZINE HYDROCHLORIDE

HYDRALAZINE HYDROCHLORIDE

Generic (ANDA)ANDA 211010DISCN MACLEODS PHARMS LTD
View HYDRALAZINE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Aug 21, 2024

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 21, 2024

    1 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HYDRALAZINE HYDROCHLORIDE

Strength

10MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 211010

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

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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