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FDA ANDA · ANDA078194

PAROXETINE HYDROCHLORIDE

Sponsor: SUN PHARM INDS INC

APPLICATION
ANDA078194
TYPE
ANDA
ORIGINAL APPROVAL
2007-06-29
LATEST ACTION
2017-07-14
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

2017-07-14Labeling · Supplement 14 · standardAP
2017-07-14Manufacturing (CMC) · Supplement 12 · unknownAP
2017-07-14Labeling · Supplement 13 · standardAP
2009-03-11Labeling · Supplement 6AP
2008-12-15Labeling · Supplement 4AP
2008-05-29Labeling · Supplement 2AP
2007-06-29Original — 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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