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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074215
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET;ORAL Discontinued None No No
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET;ORAL Discontinued None No No
ALPRAZOLAM ALPRAZOLAM 1MG TABLET;ORAL Discontinued None No No
ALPRAZOLAM ALPRAZOLAM 2MG TABLET;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
01/27/1994 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
12/31/2019 SUPPL-24 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/27/2011 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

06/01/2012 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

06/28/2008 SUPPL-18 Labeling

Label is not available on this site.

04/03/2002 SUPPL-6 Labeling

Label is not available on this site.

10/18/2000 SUPPL-5 Labeling

Label is not available on this site.

05/06/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/03/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/07/1997 SUPPL-1 Labeling

Label is not available on this site.

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