Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020716
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VICOPROFEN HYDROCODONE BITARTRATE; IBUPROFEN 7.5MG;200MG TABLET;ORAL Discontinued None Yes 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
09/23/1997 ORIG-1 Approval Type 4 - New Combination STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020716_vicoprofen_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/16/2016 SUPPL-16 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020716s012s013s014s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020716Orig1s012,s013,s014,s015,s016ltr.pdf
12/16/2016 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020716s012s013s014s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020716Orig1s012,s013,s014,s015,s016ltr.pdf
12/16/2016 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020716s012s013s014s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020716Orig1s012,s013,s014,s015,s016ltr.pdf
12/16/2016 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020716s012s013s014s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020716Orig1s012,s013,s014,s015,s016ltr.pdf
12/16/2016 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020716s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020716Orig1s012,s013,s014,s015,s016ltr.pdf
08/27/2012 SUPPL-11 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020716Orig1s011ltr.pdf
07/25/2008 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020716s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020716s010ltr.pdf
10/26/2006 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020716s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020716s008ltr.pdf
12/02/2002 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/13/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

02/13/2001 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

03/14/2000 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/17/1998 SUPPL-1 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
12/16/2016 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020716s012s013s014s015s016lbl.pdf
12/16/2016 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020716s012s013s014s015s016lbl.pdf
12/16/2016 SUPPL-15 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020716s012s013s014s015s016lbl.pdf
12/16/2016 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020716s012s013s014s015s016lbl.pdf
12/16/2016 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020716s012s013s014s015s016lbl.pdf
12/16/2016 SUPPL-13 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020716s012s013s014s015s016lbl.pdf
12/16/2016 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020716s012s013s014s015s016lbl.pdf
12/16/2016 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020716s012s013s014s015s016lbl.pdf
12/16/2016 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020716s012lbl.pdf
07/25/2008 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020716s010lbl.pdf
10/26/2006 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020716s008lbl.pdf

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