← FDA DRUG APPROVALS

FDA ANDA · ANDA212143

FOSAPREPITANT

fosaprepitant dimeglumine

Sponsor: CHIA TAI TIANQING

APPLICATION
ANDA212143
TYPE
ANDA
ORIGINAL APPROVAL
2021-03-03
LATEST ACTION
2026-06-10
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

FOSAPREPITANT DIMEGLUMINEPrescription
FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL · POWDER · INTRAVENOUS

Approval history

2026-06-10Labeling · Supplement 4 · standardAP
2024-09-16Labeling · Supplement 2 · standardAP
2021-03-03UNKNOWN · Original · standardAP
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 →