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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076379
Company: PADAGIS US

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP;ORAL Prescription AA No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/02/2005 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/17/2023 SUPPL-11 Labeling-Package Insert

Label is not available on this site.
04/27/2017 SUPPL-8 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
04/27/2017 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

MIDAZOLAM HYDROCHLORIDE

SYRUP;ORAL; EQ 2MG BASE/ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP;ORAL Prescription No AA 075873 HIKMA
MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP;ORAL Prescription No AA 076379 PADAGIS US
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