Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040094
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 650MG;7.5MG TABLET;ORAL Discontinued None No No
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 650MG;10MG TABLET;ORAL Discontinued None No No
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 660MG;10MG TABLET;ORAL Discontinued None No No
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 750MG;10MG 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
09/29/1995 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
01/09/2008 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

08/08/2002 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/2002 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/2002 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/2002 SUPPL-20 Manufacturing (CMC)-Facility

Label is not available on this site.

12/15/2000 SUPPL-16 Labeling

Label is not available on this site.

08/08/2000 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/29/2000 SUPPL-14 Labeling

Label is not available on this site.

10/29/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/08/2000 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/08/2000 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/08/2000 SUPPL-9 Labeling

Label is not available on this site.

08/08/2000 SUPPL-8 Manufacturing (CMC)-New Strength

Label is not available on this site.

10/07/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/04/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/08/1997 SUPPL-5 Labeling

Label is not available on this site.

03/22/1999 SUPPL-4 Labeling

Label is not available on this site.

03/22/1999 SUPPL-3 Manufacturing (CMC)-New Strength

Label is not available on this site.

12/04/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/04/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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