APPLICATION
ANDA075637
TYPE
ANDA
ORIGINAL APPROVAL
2000-10-31
LATEST ACTION
2023-01-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
MIDAZOLAM HYDROCHLORIDEDiscontinued
MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML · INJECTABLE · INJECTION
MIDAZOLAM HYDROCHLORIDEDiscontinued
MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML · INJECTABLE · INJECTION
Approval history
2023-01-17Labeling · Supplement 17 · standardAP
2017-04-27Labeling · Supplement 13 · standardAP
2017-04-27Labeling · Supplement 12 · standardAP
2002-11-20Manufacturing (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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