Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074294
Company: IVAX SUB TEVA PHARMS
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
07/29/1994 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
05/30/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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