Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089160
Company: MALLINCKRODT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANEXSIA ACETAMINOPHEN; HYDROCODONE BITARTRATE 500MG;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
04/23/1987 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
11/13/2002 SUPPL-37 Labeling

Label is not available on this site.

11/05/2002 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

07/15/2002 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

09/19/2002 SUPPL-34 Labeling

Label is not available on this site.

09/19/2002 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/11/2002 SUPPL-32 Manufacturing (CMC)-Facility

Label is not available on this site.

03/15/2000 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

03/15/2000 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

03/15/2000 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

03/15/2000 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

03/15/2000 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

03/15/2000 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

03/15/2000 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/15/2000 SUPPL-24 Labeling

Label is not available on this site.

03/15/2000 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

03/15/2000 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

03/15/2000 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/30/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/11/1997 SUPPL-12 Labeling

Label is not available on this site.

05/12/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/12/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/12/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/19/1995 SUPPL-7 Labeling

Label is not available on this site.

06/21/1991 SUPPL-6 Labeling

Label is not available on this site.

09/30/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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