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FDA ANDA · ANDA203460
MIDAZOLAM
midazolam hydrochloride
Sponsor: FRESENIUS KABI USA
APPLICATION
ANDA203460
TYPE
ANDA
ORIGINAL APPROVAL
2014-08-22
LATEST ACTION
2023-01-17
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREEPrescription
MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML · INJECTABLE · INJECTION
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREEPrescription
MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML · INJECTABLE · INJECTION
Approval history
2023-01-17Labeling · Supplement 10 · standardAP
2020-05-26Labeling · Supplement 9 · standardAP
2017-06-05Labeling · Supplement 5 · standardAP
2017-06-05Labeling · Supplement 6 · standardAP
2016-12-27Labeling · Supplement 4 · standardAP
2014-08-22UNKNOWN · OriginalAP
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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