Assyro AI

Orange Book product · Generic (ANDA)

GRANISETRON HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE

Generic (ANDA)ANDA 078725DISCN AUROBINDO PHARMA USA

At a glance

Jan 30, 2008

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 30, 2008

    18 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

GRANISETRON HYDROCHLORIDE

Strength

EQ 1MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 078725

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of GRANISETRON 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.