APPLICATION
ANDA075856
TYPE
ANDA
ORIGINAL APPROVAL
2002-06-13
LATEST ACTION
2017-04-27
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
MIDAZOLAM HYDROCHLORIDEDiscontinued
MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML · INJECTABLE · INJECTION
MIDAZOLAM HYDROCHLORIDEDiscontinued
MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML · INJECTABLE · INJECTION
Approval history
2017-04-27Labeling · Supplement 11 · standardAP
2017-04-27Labeling · Supplement 12 · standardAP
2015-05-04Labeling · Supplement 9AP
2002-06-13OriginalAP
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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