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FDA NDA · NDA216359

N/A

midazolam injection, 10 mg

Sponsor: RAFA LABS LTD

APPLICATION
NDA216359
TYPE
NDA
ORIGINAL APPROVAL
2022-08-08
LATEST ACTION
2024-05-02
ROUTE
INTRAMUSCULAR
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) · ReferencePrescription
MIDAZOLAM HYDROCHLORIDE EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML) · SOLUTION · INTRAMUSCULAR

Approval history

2024-05-02Manufacturing (CMC) · Supplement 2LabelAP
2022-08-08Type 5 - New Formulation or New Manufacturer · Original · priorityLabelAP
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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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