Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040468
Company: MALLINCKRODT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANEXSIA ACETAMINOPHEN; HYDROCODONE BITARTRATE 750MG;10MG 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
10/31/2002 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
06/24/2011 SUPPL-7 Labeling

Label is not available on this site.

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