APPLICATION
ANDA075873
TYPE
ANDA
ORIGINAL APPROVAL
2002-04-30
LATEST ACTION
2024-11-18
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription
Products
MIDAZOLAM HYDROCHLORIDEPrescription
MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML · SYRUP · ORAL
Approval history
2024-11-18Manufacturing (CMC) · Supplement 14 · unknownAP
2023-01-17Labeling · Supplement 13 · standardAP
2017-04-27Labeling · Supplement 10 · standardAP
2017-04-27Labeling · Supplement 11 · standardAP
2007-12-12Labeling · Supplement 6AP
2004-05-20Labeling · Supplement 3AP
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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