Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089736
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VICODIN ES ACETAMINOPHEN; HYDROCODONE BITARTRATE 750MG;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
12/09/1988 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/089736.PDF
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/26/2006 SUPPL-13 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/089736s013lbl.pdf
04/02/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

06/27/2000 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/16/2000 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

03/25/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/28/1992 SUPPL-8 Labeling

Label is not available on this site.

07/17/1991 SUPPL-7 Labeling

Label is not available on this site.

07/17/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/17/1991 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/17/1991 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/17/1991 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/17/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/17/1991 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/26/2006 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/089736s013lbl.pdf

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