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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084386
Company: WYETH AYERST
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIGOXIN DIGOXIN 0.25MG/ML INJECTABLE;INJECTION 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
07/12/1976 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
08/25/1998 SUPPL-12 Labeling

Label is not available on this site.

03/10/1993 SUPPL-11 Labeling

Label is not available on this site.

02/15/1991 SUPPL-9 Labeling

Label is not available on this site.

03/12/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/30/1984 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

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