APPLICATION
ANDA076379
TYPE
ANDA
ORIGINAL APPROVAL
2005-05-02
LATEST ACTION
2023-01-17
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription
Products
MIDAZOLAM HYDROCHLORIDEPrescription
MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML · SYRUP · ORAL
Approval history
2023-01-17Labeling · Supplement 11 · standardAP
2017-04-27Labeling · Supplement 7 · standardAP
2017-04-27Labeling · Supplement 8 · standardAP
2005-05-02OriginalAP
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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