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FDA NDA · NDA212157

ELYXYB - CELECOXIB

celecoxib

Sponsor: SCILEX PHARMS

APPLICATION
NDA212157
TYPE
NDA
ORIGINAL APPROVAL
2020-05-05
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ELYXYB · ReferencePrescription
CELECOXIB 25MG/ML · SOLUTION · ORAL

Approval history

2024-11-21Labeling · Supplement 3 · standard — Letter ↗AP
2021-04-28Labeling · Supplement 2 · standard — Letter ↗AP
2020-05-05Type 3 - New Dosage Form · 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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