APPLICATION
ANDA212645
TYPE
ANDA
ORIGINAL APPROVAL
2021-08-27
LATEST ACTION
2024-08-29
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
PAROXETINE HYDROCHLORIDEPrescription
PAROXETINE HYDROCHLORIDE EQ 37.5MG BASE · TABLET, EXTENDED RELEASE · ORAL
PAROXETINE HYDROCHLORIDEPrescription
PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE · TABLET, EXTENDED RELEASE · ORAL
PAROXETINE HYDROCHLORIDEPrescription
PAROXETINE HYDROCHLORIDE EQ 25MG BASE · TABLET, EXTENDED RELEASE · ORAL
Approval history
2024-08-29Labeling · Supplement 4 · standardAP
2024-08-29Labeling · Supplement 2 · standardAP
2023-03-23Labeling · Supplement 1 · standardAP
2021-08-27UNKNOWN · Original · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.