APPLICATION
ANDA218454
TYPE
ANDA
ORIGINAL APPROVAL
2025-05-01
LATEST ACTION
2025-05-01
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
MIDAZOLAM IN 0.8% SODIUM CHLORIDEPrescription
MIDAZOLAM 100MG/100ML (1MG/ML) · SOLUTION · INTRAVENOUS
MIDAZOLAM IN 0.8% SODIUM CHLORIDEPrescription
MIDAZOLAM 50MG/50ML (1MG/ML) · SOLUTION · INTRAVENOUS
Approval history
2025-05-01UNKNOWN · Original · standardAP
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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