← FDA DRUG APPROVALS

FDA ANDA · ANDA203939

FOSAPREPITANT DIMEGLUMINE

Sponsor: CAPLIN

APPLICATION
ANDA203939
TYPE
ANDA
ORIGINAL APPROVAL
2020-12-08
LATEST ACTION
2026-07-28
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued

Products

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

Approval history

2026-07-28Labeling · Supplement 4 · standardAP
2023-05-01Labeling · Supplement 2 · standardAP
2023-05-01Labeling · Supplement 3 · standardAP
2020-12-08UNKNOWN · OriginalAP
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 →