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FDA NDA · NDA214900

BREXAFEMME

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA214900
TYPE
NDA
ORIGINAL APPROVAL
2021-06-01
LATEST ACTION
2026-07-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BREXAFEMME · ReferencePrescription
IBREXAFUNGERP CITRATE EQ 150MG BASE · TABLET · ORAL

Approval history

2026-07-24Labeling · Supplement 4 · standard — Label ↗AP
2025-11-03Labeling · Supplement 3 · standard — Label ↗AP
2022-11-30Efficacy · Supplement 2 · priority — Letter ↗AP
2022-06-15Labeling · Supplement 1 · standard — Letter ↗AP
2021-06-01Type 1 - New Molecular Entity · Original · priority — 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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