Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090315
Company: MYLAN ASI
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE;INJECTION Discontinued None No No
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE;INJECTION Discontinued None 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
11/29/2010 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
04/27/2017 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

04/27/2017 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

10/14/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

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