Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 060624
Company: WYETH AYERST
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMNIPEN (AMPICILLIN) AMPICILLIN/AMPICILLIN TRIHYDRATE 250MG CAPSULE;ORAL Discontinued None No No
OMNIPEN (AMPICILLIN) AMPICILLIN/AMPICILLIN TRIHYDRATE 500MG CAPSULE;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
12/17/1965 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
08/13/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/30/1993 SUPPL-1 Labeling

Label is not available on this site.

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