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FDA ANDA · ANDA075716

PAROXETINE HYDROCHLORIDE

Sponsor: PHARMOBEDIENT

APPLICATION
ANDA075716
TYPE
ANDA
ORIGINAL APPROVAL
2004-03-08
LATEST ACTION
2024-07-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PAROXETINE HYDROCHLORIDEDiscontinued
PAROXETINE HYDROCHLORIDE EQ 30MG BASE · TABLET · ORAL
PAROXETINE HYDROCHLORIDEDiscontinued
PAROXETINE HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
PAROXETINE HYDROCHLORIDEDiscontinued
PAROXETINE HYDROCHLORIDE EQ 40MG BASE · TABLET · ORAL
PAROXETINE HYDROCHLORIDEDiscontinued
PAROXETINE HYDROCHLORIDE EQ 20MG BASE · TABLET · ORAL

Approval history

2024-07-08Labeling · Supplement 13 · standardAP
2009-03-06Labeling · Supplement 11AP
2007-07-09Labeling · Supplement 9AP
2007-07-09Labeling · Supplement 10AP
2007-02-27Labeling · Supplement 6AP
2007-02-27Labeling · Supplement 5AP
2006-03-24Labeling · Supplement 4AP
2005-10-25Labeling · Supplement 3AP
2005-03-10Labeling · Supplement 2AP
2004-03-08Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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