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FDA ANDA · ANDA076058

MIDAZOLAM HYDROCHLORIDE

Sponsor: SUN PHARM INDS LTD

APPLICATION
ANDA076058
TYPE
ANDA
ORIGINAL APPROVAL
2002-03-15
LATEST ACTION
2017-04-27
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued

Products

MIDAZOLAM HYDROCHLORIDEDiscontinued
MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML · SYRUP · ORAL

Approval history

2017-04-27Labeling · Supplement 8 · standardAP
2017-04-27Labeling · Supplement 7 · standardAP
2002-03-15Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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