APPLICATION
ANDA090696
TYPE
ANDA
ORIGINAL APPROVAL
2012-02-29
LATEST ACTION
2023-01-17
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MIDAZOLAM HYDROCHLORIDEPrescription
MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML · INJECTABLE · INJECTION
Approval history
2023-01-17Labeling · Supplement 13 · standardAP
2017-04-27Labeling · Supplement 7 · standardAP
2017-04-27Labeling · Supplement 8 · standardAP
2012-08-28Labeling · Supplement 2 · standardAP
2012-06-20Labeling · Supplement 1 · standardAP
2012-02-29OriginalAP
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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