FDA NDA · NDA215133

SERTRALINE HYDROCHLORIDE

Sponsor: ALMATICA

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APPLICATION
NDA215133
TYPE
NDA
ORIGINAL APPROVAL
2021-10-04
LATEST ACTION
2026-10-06
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

SERTRALINE HYDROCHLORIDE · ReferencePrescription
SERTRALINE HYDROCHLORIDE EQ 150MG BASE · CAPSULE · ORAL
SERTRALINE HYDROCHLORIDE · ReferencePrescription
SERTRALINE HYDROCHLORIDE EQ 200MG BASE · CAPSULE · ORAL

Approval history

2026-10-06Labeling · Supplement 4 · standard — Label ↗AP
2023-08-18Labeling · Supplement 1 · standard — Label ↗AP
2021-10-04Type 3 - New Dosage Form · Original · standard — Label ↗AP
2021-10-04Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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