NDA 019111

UCB INC

FDA Drug Application

Application #019111

Documents

• Letter: 2003-11-25
• Label: 2008-03-13
• Letter: 2008-03-13
• Letter: 2011-06-09
• Letter: 2015-04-03
• Review: 2008-08-01
• Label: 2015-04-02
• Other Important Information from FDA: 2008-03-13
• Label: 2017-01-13
• Letter: 2017-01-24
• Label: 2018-07-05
• Medication Guide: 2018-07-06
• Letter: 2018-07-06

Application Sponsors

NDA 019111

UCB INC

Marketing Status

• Discontinued: 001

Application Products

001

SUSPENSION, EXTENDED RELEASE;ORAL

EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

TUSSIONEX PENNKINETIC

CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1987-12-31	STANDARD
LABELING; Labeling	SUPPL	2	AP	1993-11-26
LABELING; Labeling	SUPPL	3	AP	1993-11-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1996-12-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1999-07-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-02-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-03-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-11-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-06-07	STANDARD
LABELING; Labeling	SUPPL	11	AP	2003-11-12	STANDARD
LABELING; Labeling	SUPPL	15	AP	2008-03-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2011-06-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2014-03-21	STANDARD
LABELING; Labeling	SUPPL	18	AP	2015-04-01	STANDARD
LABELING; Labeling	SUPPL	19	AP	2017-01-13	STANDARD
LABELING; Labeling	SUPPL	22	AP	2018-06-28	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	8	Null	0
SUPPL	9	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	15
SUPPL	19	Null	6
SUPPL	22	Null	15

CDER Filings

UCB INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19111
            [companyName] => UCB INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/019111s022lbl.pdf#page=25"]
            [products] => [{"drugName":"TUSSIONEX PENNKINETIC","activeIngredients":"CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX","strength":"EQ 8MG MALEATE\/5ML;EQ 10MG BITARTRATE\/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SUSPENSION, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"06\/28\/2018","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019111s022lbl.pdf\"}]","notes":""},{"actionDate":"01\/13\/2017","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019111s019lbl.pdf\"}]","notes":""},{"actionDate":"04\/01\/2015","submission":"SUPPL-18","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/019111s018lbl.pdf\"}]","notes":""},{"actionDate":"04\/01\/2015","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/019111s018lbl.pdf\"}]","notes":""},{"actionDate":"03\/11\/2008","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/019111s015lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TUSSIONEX PENNKINETIC","submission":"CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX","actionType":"EQ 8MG MALEATE\/5ML;EQ 10MG BITARTRATE\/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SUSPENSION, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-06-28
        )

)