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FDA NDA · NDA204516

PAROXETINE

Sponsor: LEGACY

APPLICATION
NDA204516
TYPE
NDA
ORIGINAL APPROVAL
2013-06-28
LATEST ACTION
2025-02-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

BRISDELLE · ReferencePrescription
PAROXETINE MESYLATE EQ 7.5MG BASE · CAPSULE · ORAL

Approval history

2025-02-11Labeling · Supplement 9 · standard — Letter ↗AP
2025-02-11Labeling · Supplement 14 · standard — Letter ↗AP
2023-08-18Labeling · Supplement 13 · standard — Label ↗AP
2021-09-20Labeling · Supplement 11 · standard — Label ↗AP
2017-04-28Labeling · Supplement 5 · standard — Label ↗AP
2017-01-04Labeling · Supplement 4 · standard — Label ↗AP
2014-12-01Labeling · Supplement 3 · standard — Label ↗AP
2014-04-01Manufacturing (CMC) · Supplement 2 · standardAP
2013-12-19Manufacturing (CMC) · Supplement 1 · standardAP
2013-06-28Type 3 - New Dosage Form · Original · standard — Label ↗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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