NDA 050786

ALLERGAN

FDA Drug Application

Application #050786

Documents

• Letter: 2011-01-24
• Label: 2007-05-29
• Letter: 2006-10-02
• Letter: 2007-05-29
• Letter: 2013-01-25
• Label: 2013-01-24
• Review: 2006-11-22
• Label: 2017-01-25
• Letter: 2017-01-27
• Label: 2017-06-01
• Letter: 2017-06-02
• Letter: 2018-01-30
• Label: 2018-02-06
• Label: 2018-10-10
• Letter: 2018-10-11
• Letter: 2021-03-09
• Label: 2021-03-09
• Label: 2021-12-17
• Letter: 2021-12-21

Application Sponsors

NDA 050786

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

140MG;125MG;125MG

1

PYLERA

BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination	ORIG	1	AP	2006-09-28	STANDARD
LABELING; Labeling	SUPPL	3	AP	2011-01-19	STANDARD
LABELING; Labeling	SUPPL	7	AP	2013-01-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2013-08-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2013-08-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2014-05-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2014-02-05	STANDARD
LABELING; Labeling	SUPPL	12	AP	2017-01-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2016-02-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2017-01-19	STANDARD
LABELING; Labeling	SUPPL	16	AP	2017-05-30	STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; Labeling	SUPPL	17	AP	2018-01-25	STANDARD
LABELING; Labeling	SUPPL	19	AP	2018-10-05	STANDARD
LABELING; Labeling	SUPPL	23	AP	2021-03-05	STANDARD
LABELING; Labeling	SUPPL	25	AP	2021-12-15	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	3	Null	6
SUPPL	7	Null	6
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	6
SUPPL	14	Null	0
SUPPL	16	Null	6
SUPPL	17	Null	6
SUPPL	19	Null	15
SUPPL	23	Null	6
SUPPL	25	Null	6

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50786
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"PYLERA","activeIngredients":"BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE","strength":"140MG;125MG;125MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/05\/2018","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050786s019lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2018","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050786s017lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2018","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050786s017lbl.pdf\"}]","notes":""},{"actionDate":"05\/30\/2017","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050786s016lbl.pdf\"}]","notes":"Please see"},{"actionDate":"01\/25\/2017","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050786s012lbl.pdf\"}]","notes":""},{"actionDate":"01\/23\/2013","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050786s007lbl.pdf\"}]","notes":""},{"actionDate":"01\/23\/2013","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050786s007lbl.pdf\"}]","notes":""},{"actionDate":"05\/24\/2007","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050786s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/24\/2007","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050786s001lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PYLERA","submission":"BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE","actionType":"140MG;125MG;125MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-10-05
        )

)