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FDA ANDA · ANDA090316
MIDAZOLAM
midazolam hydrochloride
Sponsor: ONESOURCE SPECIALTY
APPLICATION
ANDA090316
TYPE
ANDA
ORIGINAL APPROVAL
2011-05-04
LATEST ACTION
2023-01-17
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MIDOZALAM HYDROCHLORIDEPrescription
MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML · INJECTABLE · INJECTION
MIDOZALAM HYDROCHLORIDEPrescription
MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML · INJECTABLE · INJECTION
Approval history
2023-01-17Labeling · Supplement 11 · standardAP
2017-07-17Labeling · Supplement 9 · standardAP
2017-04-27Labeling · Supplement 8 · standardAP
2017-04-27Labeling · Supplement 7 · standardAP
2011-05-04OriginalAP
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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