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FDA ANDA · ANDA216159

MIDAZOLAM IN SODIUM CHLORIDE

Sponsor: HIKMA

APPLICATION
ANDA216159
TYPE
ANDA
ORIGINAL APPROVAL
2023-04-17
LATEST ACTION
2025-06-23
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

MIDAZOLAM IN 0.9% SODIUM CHLORIDEPrescription
MIDAZOLAM 100MG/100ML (1MG/ML) · SOLUTION · INTRAVENOUS
MIDAZOLAM IN 0.9% SODIUM CHLORIDEPrescription
MIDAZOLAM 50MG/50ML (1MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2025-06-23Labeling · Supplement 2 · standardAP
2023-04-17UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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