Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087722
Company: UCB INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LORTAB 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
07/09/1982 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
12/26/2000 SUPPL-39 Manufacturing (CMC)-Facility

Label is not available on this site.

06/29/1999 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

04/25/1996 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

03/01/1996 SUPPL-36 Labeling

Label is not available on this site.

09/29/1994 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

01/21/1994 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

07/30/1993 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

02/26/1993 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

02/26/1993 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

03/06/1992 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

11/12/1991 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

06/06/1990 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

12/14/1988 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

12/14/1988 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

12/14/1988 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

10/29/1998 SUPPL-22 Labeling

Label is not available on this site.

10/29/1998 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

10/29/1998 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

10/29/1998 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/24/1986 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

11/14/1985 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/13/1985 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/13/1985 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/13/1985 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/13/1985 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/13/1985 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/13/1984 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/13/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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