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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 081095
Company: MIKART
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE 150MG;180MG;15MG 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
10/26/1990 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
07/31/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/09/1991 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/09/1991 SUPPL-2 Labeling

Label is not available on this site.

12/09/1991 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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