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FDA ANDA · ANDA076618

PAROXETINE HYDROCHLORIDE

Sponsor: CHARTWELL RX

APPLICATION
ANDA076618
TYPE
ANDA
ORIGINAL APPROVAL
2005-08-15
LATEST ACTION
2023-01-20
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

2023-01-20Labeling · Supplement 23 · standardAP
2020-04-20Labeling · Supplement 21 · standardAP
2014-12-21Labeling · Supplement 20 · standardAP
2013-12-31Labeling · Supplement 19 · standardAP
2011-12-27Labeling · Supplement 18AP
2011-07-27Labeling · Supplement 17AP
2011-01-21Labeling · Supplement 16AP
2010-03-25Labeling · Supplement 15AP
2009-10-15Labeling · Supplement 13AP
2009-03-16Labeling · Supplement 12AP
2009-03-16Labeling · Supplement 10AP
2009-03-16Labeling · Supplement 11AP
2008-02-27Labeling · Supplement 9AP
2008-02-27Labeling · Supplement 7AP
2007-03-29Labeling · Supplement 3AP
2006-03-24Labeling · Supplement 1AP
2005-08-15Original — 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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