Assyro AI

Orange Book product · Generic (ANDA)

ALPRAZOLAM

ALPRAZOLAM

Generic (ANDA)ANDA 078469DISCN PH HEALTH

At a glance

Sep 29, 2011

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 29, 2011

    14 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ALPRAZOLAM

Strength

0.5MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

ANDA 078469

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ALPRAZOLAM

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.