Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074046
Company: MYLAN PHARMS INC
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
10/19/1993 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
05/07/2007 SUPPL-6 Labeling

Label is not available on this site.

11/19/2001 SUPPL-4 Labeling

Label is not available on this site.

12/22/2000 SUPPL-3 Labeling

Label is not available on this site.

05/07/1997 SUPPL-2 Labeling

Label is not available on this site.

05/07/1997 SUPPL-1 Manufacturing (CMC)-New Strength

Label is not available on this site.

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