Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020716
Company: ABBVIE
Company: ABBVIE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VICOPROFEN | HYDROCODONE BITARTRATE; IBUPROFEN | 7.5MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |