ANDA 089736

ABBVIE

FDA Drug Application

Application #089736

Documents

• Label: 2006-12-27
• Review: 2005-07-22

Application Sponsors

ANDA 089736

ABBVIE

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

750MG;7.5MG

0

VICODIN ES

ACETAMINOPHEN; HYDROCODONE BITARTRATE

FDA Submissions

	ORIG	1	AP	1988-12-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1991-07-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1991-07-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1991-07-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1991-07-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1991-07-17
LABELING; Labeling	SUPPL	7	AP	1991-07-17
LABELING; Labeling	SUPPL	8	AP	1992-09-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1999-03-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2000-03-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2000-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2001-04-02
LABELING; Labeling	SUPPL	13	AP	2006-12-26

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89736
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"VICODIN ES","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"750MG;7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/26\/2006","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/089736s013lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"VICODIN ES","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"750MG;7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2006-12-26
        )

)