← FDA DRUG APPROVALS

FDA ANDA · ANDA078406

PAROXETINE

paroxetine hydrochloride

Sponsor: AUROBINDO PHARMA

APPLICATION
ANDA078406
TYPE
ANDA
ORIGINAL APPROVAL
2007-07-25
LATEST ACTION
2025-03-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2025-03-13Labeling · Supplement 37 · standardAP
2024-01-16Labeling · Supplement 35 · standardAP
2022-01-19Labeling · Supplement 32 · standardAP
2022-01-19Labeling · Supplement 31 · standardAP
2020-03-19Labeling · Supplement 27 · standardAP
2020-03-19Labeling · Supplement 25 · standardAP
2014-09-24Labeling · Supplement 23 · standardAP
2013-12-31Labeling · Supplement 21 · standardAP
2012-07-31Labeling · Supplement 17AP
2011-03-04Labeling · Supplement 15AP
2010-12-10Labeling · Supplement 14AP
2009-06-15Labeling · Supplement 3AP
2009-05-06Labeling · Supplement 6AP
2009-05-06Labeling · Supplement 9AP
2008-02-06Labeling · Supplement 1AP
2007-07-25Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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