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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089699
Company: MIKART

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 500MG;7.5MG 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
08/25/1989 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
10/18/2013 SUPPL-44 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/040432s006,40556s012,40658s006, 40846s005, 89699s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040432s006,040556s012,040658s006,040846s005,089699s044ltr.pdf
11/20/2002 SUPPL-32 Labeling

Label is not available on this site.
08/13/2002 SUPPL-31 Manufacturing (CMC)-Facility

Label is not available on this site.
09/09/1998 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.
07/31/1998 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.
09/18/1996 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.
09/18/1996 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.
08/31/2000 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.
08/31/2000 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.
08/31/2000 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.
08/31/2000 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.
07/19/1995 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
02/08/1995 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
01/29/1997 SUPPL-16 Labeling

Label is not available on this site.
02/25/1993 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
06/30/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
02/25/1993 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
01/21/1992 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
07/11/1991 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
07/11/1991 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
06/21/1991 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
06/21/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
06/21/1991 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
10/18/2013 SUPPL-44 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/040432s006,40556s012,40658s006, 40846s005, 89699s044lbl.pdf
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