NDA 020716

ABBVIE

FDA Drug Application

Application #020716

Documents

• Letter: 2006-11-06
• Letter: 2008-07-31
• Letter: 2012-08-29
• Label: 2006-10-27
• Label: 2008-08-12
• Review: 2010-03-03
• Letter: 2016-12-20
• Letter: 2016-12-20
• Letter: 2016-12-20
• Letter: 2016-12-20
• Letter: 2016-12-20
• Label: 2016-12-21
• Label: 2016-12-21
• Label: 2016-12-27
• Label: 2016-12-21
• Label: 2016-12-21
• Medication Guide: 2016-12-28

Application Sponsors

NDA 020716

ABBVIE

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

7.5MG;200MG

1

VICOPROFEN

HYDROCODONE BITARTRATE; IBUPROFEN

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1997-09-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-03-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2001-02-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2001-12-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-12-02	STANDARD
LABELING; Labeling	SUPPL	8	AP	2006-10-26	STANDARD
LABELING; Labeling	SUPPL	10	AP	2008-07-25	STANDARD
LABELING; Labeling	SUPPL	11	AP	2012-08-27	STANDARD
LABELING; Labeling	SUPPL	12	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	13	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	14	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	15	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	16	AP	2016-12-16	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	11	Null	15
SUPPL	12	Null	15
SUPPL	13	Null	6
SUPPL	14	Null	6
SUPPL	15	Null	7
SUPPL	16	Null	15

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20716
            [companyName] => ABBVIE
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2016\/020716s012s013s014s015s016lbl.pdf#page=36"]
            [products] => [{"drugName":"VICOPROFEN","activeIngredients":"HYDROCODONE BITARTRATE; IBUPROFEN","strength":"7.5MG;200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/16\/2016","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020716s012s013s014s015s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020716s012s013s014s015s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-15","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020716s012s013s014s015s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020716s012s013s014s015s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020716s012s013s014s015s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-13","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020716s012s013s014s015s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020716s012s013s014s015s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020716s012s013s014s015s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020716s012lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2008","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020716s010lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2006","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020716s008lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"VICOPROFEN","submission":"HYDROCODONE BITARTRATE; IBUPROFEN","actionType":"7.5MG;200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2016-12-16
        )

)