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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077391
Company: MYLAN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALPRAZOLAM ALPRAZOLAM 3MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
ALPRAZOLAM ALPRAZOLAM 1MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
ALPRAZOLAM ALPRAZOLAM 2MG TABLET, EXTENDED RELEASE;ORAL 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
01/26/2006 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077391ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/08/2013 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
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