Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089006
Company: MALLINCKRODT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 500MG;5MG 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
08/09/1985 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
05/20/2002 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

07/20/2000 SUPPL-31 Manufacturing (CMC)-Facility

Label is not available on this site.

05/24/1996 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

03/15/1995 SUPPL-29 Labeling

Label is not available on this site.

06/05/1997 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

09/29/1994 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

12/29/1993 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

03/05/1993 SUPPL-25 Bioequivalence

Label is not available on this site.

12/02/1991 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

05/08/1991 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

11/22/1988 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

11/22/1988 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

11/22/1988 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/22/1988 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

11/22/1988 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/22/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/22/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/17/1986 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/17/1986 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/17/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/17/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/22/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/22/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/22/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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