APPLICATION
ANDA215003
TYPE
ANDA
ORIGINAL APPROVAL
2021-09-03
LATEST ACTION
2024-01-19
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
PAROXETINE HYDROCHLORIDEPrescription
PAROXETINE HYDROCHLORIDE EQ 10MG BASE/5ML · SUSPENSION · ORAL
Approval history
2024-01-19Labeling · Supplement 7 · standardAP
2023-01-31Labeling · Supplement 3 · 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.
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