APPLICATION
ANDA075293
TYPE
ANDA
ORIGINAL APPROVAL
2000-06-20
LATEST ACTION
2023-01-17
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MIDAZOLAM HYDROCHLORIDEPrescription
MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML · INJECTABLE · INJECTION
MIDAZOLAM HYDROCHLORIDEPrescription
MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML · INJECTABLE · INJECTION
Approval history
2023-01-17Labeling · Supplement 22 · standardAP
2017-04-27Labeling · Supplement 18 · standardAP
2017-04-27Labeling · Supplement 16 · standardAP
2009-05-14Labeling · Supplement 10AP
2002-10-25Manufacturing (CMC) · Supplement 4AP
2002-03-15Manufacturing (CMC) · Supplement 3AP
2001-06-07Manufacturing (CMC) · Supplement 2AP
2000-12-07Manufacturing (CMC) · Supplement 1AP
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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