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FDA NDA · NDA215133

SERTRALINE HYDROCHLORIDE

Sponsor: ALMATICA

APPLICATION
NDA215133
TYPE
NDA
ORIGINAL APPROVAL
2021-10-04
LATEST ACTION
2023-08-18
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

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 ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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