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Orange Book product · Generic (ANDA)

FLUPHENAZINE HYDROCHLORIDE

FLUPHENAZINE HYDROCHLORIDE

Generic (ANDA)ANDA 213784TE ABRX UPSHER SMITH LABS

At a glance

Oct 24, 2022

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 24, 2022

    3 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

FLUPHENAZINE HYDROCHLORIDE

Strength

1MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 213784

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of FLUPHENAZINE 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.