Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087757
Company: UCB INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CO-GESIC 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
05/03/1982 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
01/26/2008 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

11/29/1999 SUPPL-27 Manufacturing (CMC)-Facility

Label is not available on this site.

12/09/1998 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

04/30/1996 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

12/20/1994 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

12/06/1995 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

12/06/1995 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

12/06/1995 SUPPL-21 Labeling

Label is not available on this site.

12/06/1995 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

08/30/1991 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/15/1989 SUPPL-17 Labeling

Label is not available on this site.

03/29/1990 SUPPL-16 Labeling

Label is not available on this site.

02/07/1989 SUPPL-15 Labeling

Label is not available on this site.

04/20/1989 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/29/1992 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/29/1986 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/13/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/24/1984 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/24/1984 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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