APPLICATION
ANDA202825
TYPE
ANDA
ORIGINAL APPROVAL
2014-11-07
LATEST ACTION
2024-11-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SERTRALINE HYDROCHLORIDEPrescription
SERTRALINE HYDROCHLORIDE EQ 100MG BASE · TABLET · ORAL
SERTRALINE HYDROCHLORIDEPrescription
SERTRALINE HYDROCHLORIDE EQ 25MG BASE · TABLET · ORAL
SERTRALINE HYDROCHLORIDEPrescription
SERTRALINE HYDROCHLORIDE EQ 50MG BASE · TABLET · ORAL
Approval history
2024-11-07Labeling · Supplement 11 · standardAP
2024-11-07Labeling · Supplement 12 · standardAP
2024-11-07Labeling · Supplement 10 · standardAP
2018-05-08Labeling · Supplement 2 · standardAP
2018-05-08Labeling · Supplement 1 · standardAP
2014-11-07UNKNOWN · OriginalAP
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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