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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089883
Company: WATSON LABS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN 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
12/01/1988 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
03/20/2008 SUPPL-42 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.
01/09/2008 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.
08/08/2002 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.
08/08/2002 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.
05/21/2002 SUPPL-22 Manufacturing (CMC)-Facility

Label is not available on this site.
09/05/2001 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.
03/15/2000 SUPPL-20 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.
03/29/2000 SUPPL-19 Labeling

Label is not available on this site.
10/29/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
10/07/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
12/04/1997 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
08/08/1997 SUPPL-15 Labeling

Label is not available on this site.
12/04/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
12/04/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
05/10/1996 SUPPL-12 Labeling

Label is not available on this site.
12/22/1995 SUPPL-11 Labeling

Label is not available on this site.
10/20/1994 SUPPL-10 Labeling

Label is not available on this site.
05/28/1993 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
05/28/1993 SUPPL-8 Labeling

Label is not available on this site.
05/28/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
04/08/1992 SUPPL-6 Labeling

Label is not available on this site.
03/04/1992 SUPPL-5 Labeling

Label is not available on this site.
10/12/1990 SUPPL-4 Labeling

Label is not available on this site.
06/07/1990 SUPPL-3 Labeling

Label is not available on this site.
02/03/1989 SUPPL-1 Labeling

Label is not available on this site.
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