Assyro AI

Orange Book product · Generic (ANDA)

PAROXETINE HYDROCHLORIDE

PAROXETINE HYDROCHLORIDE

Generic (ANDA)ANDA 077584TE ABRX ZYDUS PHARMS USA

At a glance

Mar 07, 2007

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 07, 2007

    19 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

PAROXETINE HYDROCHLORIDE

Strength

EQ 10MG BASE

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 077584

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of PAROXETINE 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.