Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088058
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VICODIN 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
01/07/1983 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
12/26/2006 SUPPL-27 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/088058s027lbl.pdf
04/02/2001 SUPPL-24 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf
06/27/2000 SUPPL-23 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf
03/16/2000 SUPPL-22 Manufacturing (CMC)-Facility Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf
02/15/2000 SUPPL-21 Manufacturing (CMC)-Facility Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf
09/10/1992 SUPPL-20 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf
08/20/1992 SUPPL-19 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf
08/20/1992 SUPPL-18 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf
01/19/1988 SUPPL-17 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf
02/29/1988 SUPPL-14 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf
02/29/1988 SUPPL-13 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf
05/11/1987 SUPPL-12 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf
05/11/1987 SUPPL-11 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf
05/11/1987 SUPPL-9 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf
05/11/1987 SUPPL-8 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf
06/24/1986 SUPPL-7 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf
06/24/1986 SUPPL-6 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf
11/26/1984 SUPPL-5 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf
11/26/1984 SUPPL-3 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf
11/26/1984 SUPPL-2 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf
11/26/1984 SUPPL-1 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/088058s001_thru_024.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/26/2006 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/088058s027lbl.pdf

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