Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089363
Company: MIKART
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 650MG;60MG 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
09/25/1991 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
08/13/2002 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

07/31/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/21/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/04/1994 SUPPL-1 Labeling

Label is not available on this site.

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