Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088956
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
07/19/1985 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
07/20/2000 SUPPL-32 Manufacturing (CMC)-Facility

Label is not available on this site.

04/10/1996 SUPPL-30 Labeling

Label is not available on this site.

06/05/1997 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

09/29/1994 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

12/21/1993 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

12/16/1991 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/03/1991 SUPPL-24 Labeling

Label is not available on this site.

06/04/1990 SUPPL-23 Labeling

Label is not available on this site.

07/11/1991 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

11/03/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/03/1989 SUPPL-10 Labeling

Label is not available on this site.

11/03/1989 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/03/1989 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/06/1989 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/06/1989 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/06/1989 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/03/1989 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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