Assyro AI

Orange Book product · Generic (ANDA)

FLUPHENAZINE DECANOATE

FLUPHENAZINE DECANOATE

Generic (ANDA)ANDA 074531TE AORX HIKMA

At a glance

Aug 30, 1996

Approved

Generic (ANDA)

Application

AO

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 30, 1996

    30 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

FLUPHENAZINE DECANOATE

Strength

25MG/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

AO

Application

ANDA 074531

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 DECANOATE

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.