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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040698
Company: MIKART
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 400MG;7.5MG 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
04/27/2006 ORIG-1 Approval

Label is not available on this site.

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