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FDA ANDA · ANDA210625

FOSAPREPITANT DIMEGLUMINE

Sponsor: EUGIA PHARMA

APPLICATION
ANDA210625
TYPE
ANDA
ORIGINAL APPROVAL
2021-01-12
LATEST ACTION
2023-10-10
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

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

Approval history

2023-10-10Labeling · Supplement 3 · standardAP
2023-10-10Labeling · Supplement 1 · standardAP
2023-10-10Labeling · Supplement 4 · standardAP
2021-01-12UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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