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FDA ANDA · ANDA203854

PAROXETINE

paroxetine hydrochloride hemihydrate

Sponsor: PRINSTON INC

APPLICATION
ANDA203854
TYPE
ANDA
ORIGINAL APPROVAL
2014-10-31
LATEST ACTION
2024-07-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2024-07-15Labeling · Supplement 4 · standardAP
2024-07-15Labeling · Supplement 3 · standardAP
2020-04-29Labeling · Supplement 1 · standardAP
2014-10-31UNKNOWN · OriginalAP
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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