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FDA ANDA · ANDA076968

PAROXETINE HYDROCHLORIDE

Sponsor: OXFORD PHARMS

APPLICATION
ANDA076968
TYPE
ANDA
ORIGINAL APPROVAL
2010-06-21
LATEST ACTION
2023-06-28
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

2023-06-28Labeling · Supplement 1 · standardAP
2023-06-28Labeling · Supplement 4 · standardAP
2010-06-21OriginalAP
VIEW ON DRUGS@FDA ↗

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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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