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FDA NDA · NDA213006

GEMTESA

vibegron

Sponsor: SUMITOMO PHARMA AM

APPLICATION
NDA213006
TYPE
NDA
ORIGINAL APPROVAL
2020-12-23
LATEST ACTION
2024-12-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

GEMTESA · ReferencePrescription
VIBEGRON 75MG · TABLET · ORAL

Approval history

2024-12-18Efficacy · Supplement 11 · standard — Label ↗AP
2024-10-08Labeling · Supplement 13 · standard — Letter ↗AP
2020-12-23Type 1 - New Molecular Entity · 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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