Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089725
Company: MALLINCKRODT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANEXSIA 7.5/650 ACETAMINOPHEN; HYDROCODONE BITARTRATE 650MG;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
09/30/1987 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-31 Labeling

Label is not available on this site.

09/27/2002 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

09/19/2002 SUPPL-29 Labeling

Label is not available on this site.

09/19/2002 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/11/2002 SUPPL-27 Manufacturing (CMC)-Facility

Label is not available on this site.

04/07/2000 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

04/07/2000 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/07/2000 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

04/07/2000 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

04/07/2000 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/07/2000 SUPPL-21 Labeling

Label is not available on this site.

04/07/2000 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/07/2000 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/07/2000 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/07/2000 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/07/2000 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/11/1997 SUPPL-15 Labeling

Label is not available on this site.

06/26/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/26/1995 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/12/1995 SUPPL-11 Manufacturing (CMC)

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.

04/19/1995 SUPPL-8 Labeling

Label is not available on this site.

05/03/1991 SUPPL-7 Labeling

Label is not available on this site.

06/29/1990 SUPPL-6 Labeling

Label is not available on this site.

06/29/1990 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/23/1989 SUPPL-4 Labeling

Label is not available on this site.

08/10/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/10/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/05/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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