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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020716
Company: ABBVIE

Medication Guide

Products on NDA 020716

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HYDROCODONE BITARTRATE; IBUPROFEN	7.5MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020716

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.html

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.

Labels for NDA 020716

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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