← FDA DRUG APPROVALS

FDA ANDA · ANDA213106

FOSAPREPITANT DIMEGLUMINE

Sponsor: QILU PHARM HAINAN

APPLICATION
ANDA213106
TYPE
ANDA
ORIGINAL APPROVAL
2020-09-08
LATEST ACTION
2023-07-25
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

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

Approval history

2023-07-25Labeling · Supplement 5 · standardAP
2023-07-25Labeling · Supplement 3 · standardAP
2020-09-08UNKNOWN · 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 →