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FDA NDA · NDA213426

SEGLENTIS

Sponsor: KOWA PHARMS

APPLICATION
NDA213426
TYPE
NDA
ORIGINAL APPROVAL
2021-10-15
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

SEGLENTIS · ReferenceDiscontinued
CELECOXIB 56MG, TRAMADOL HYDROCHLORIDE 44MG · TABLET · ORAL

Approval history

2024-11-21Labeling · Supplement 3 · standard — Label ↗AP
2024-10-31REMS · Supplement 4 — Letter ↗AP
2023-12-15Labeling · Supplement 2 · standard — Label ↗AP
2023-01-06Labeling · Supplement 1 · standard — Letter ↗AP
2021-10-15Type 4 - New Combination · Original · standard — Label ↗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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