← FDA DRUG APPROVALS

FDA NDA · NDA212327

INREBIC

Sponsor: BRISTOL-MYERS

APPLICATION
NDA212327
TYPE
NDA
ORIGINAL APPROVAL
2019-08-16
LATEST ACTION
2026-07-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

INREBIC · ReferencePrescription
FEDRATINIB HYDROCHLORIDE EQ 100MG BASE · CAPSULE · ORAL

Approval history

2026-07-20Labeling · Supplement 11 · standard — Letter ↗AP
2026-03-18Labeling · Supplement 9 · standard — Letter ↗AP
2025-05-12Labeling · Supplement 7 · standard — Letter ↗AP
2024-07-30Labeling · Supplement 6 · standard — Letter ↗AP
2023-05-15Labeling · Supplement 5 · standard — Label ↗AP
2021-12-03Labeling · Supplement 3 · standard — Label ↗AP
2021-11-23Labeling · Supplement 4 · standard — Letter ↗AP
2019-08-16Type 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →