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FDA ANDA · ANDA075154
MIDAZOLAM
midazolam hydrochloride
Sponsor: FRESENIUS KABI USA
APPLICATION
ANDA075154
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 1MG BASE/ML · INJECTABLE · INJECTION
MIDAZOLAM HYDROCHLORIDEPrescription
MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML · INJECTABLE · INJECTION
Approval history
2023-01-17Labeling · Supplement 19 · standardAP
2017-08-14Labeling · Supplement 13 · standardAP
2003-09-29Labeling · Supplement 2AP
2002-03-21Labeling · 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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