Assyro AI

Orange Book product · Generic (ANDA)

BUSPIRONE HYDROCHLORIDE

BUSPIRONE HYDROCHLORIDE

Generic (ANDA)ANDA 210907TE ABRX UNICHEM

At a glance

Nov 14, 2019

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 14, 2019

    6 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

BUSPIRONE HYDROCHLORIDE

Strength

5MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 210907

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of BUSPIRONE 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.