FDA ANDA 214850, ERIBULIN MESYLATE, LONG GROVE PHARMS, 07/18/2024

Contents: Approval letter, executive summary, quality assessment data sheets

ANDA: 214850
Company: LONG GROVE PHARMS
Drug Name: ERIBULIN MESYLATE
Active Ingredients: ERIBULIN MESYLATE
Strength: 1MG/2ML (0.5MG/ML)
Dosage Form/Route: SOLUTION;INTRAVENOUS
Action Date: 07/18/2024
Marketing Status: Prescription
Submission Classification: ORIG-1

60 Pages