NDA 019429

ALLERGAN

FDA Drug Application

Application #019429

Documents

• Label: 2008-04-28
• Letter: 2002-08-26
• Letter: 2008-04-28
• Letter: 2013-05-13
• Label: 2013-05-14
• Other: 2008-04-28
• Letter: 2016-12-20
• Label: 2016-12-21
• Label: 2017-08-30
• Letter: 2017-08-30
• Letter: 2018-09-28
• Letter: 2018-09-28
• Label: 2018-10-05
• Label: 2018-10-05
• Label: 2019-10-08
• Medication Guide: 2019-10-08
• Letter: 2019-10-08
• Letter: 2021-04-29
• Letter: 2021-04-29
• Label: 2021-05-03
• Label: 2021-05-03
• Medication Guide: 2021-05-03

Application Sponsors

NDA 019429

ALLERGAN

Marketing Status

• Prescription: 003

Application Products

003

CAPSULE;ORAL

325MG;50MG;40MG;30MG

1

FIORINAL W/CODEINE

ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1990-10-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1993-04-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1993-04-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1993-04-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1994-04-05	STANDARD
LABELING; Labeling	SUPPL	6	AP	2002-08-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1995-10-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1996-03-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1995-11-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1996-07-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1999-04-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1999-11-10	STANDARD
LABELING; Labeling	SUPPL	16	AP	2001-10-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2001-05-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2001-06-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2002-04-26	STANDARD
LABELING; Labeling	SUPPL	23	AP	2008-04-08	STANDARD
LABELING; Labeling	SUPPL	35	AP	2013-05-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	2014-11-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	2015-11-06	STANDARD
LABELING; Labeling	SUPPL	39	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	40	AP	2017-08-29	STANDARD
REMS; REMS	SUPPL	41	AP	2018-09-18	N/A
LABELING; Labeling	SUPPL	42	AP	2018-09-18	STANDARD
LABELING; Labeling	SUPPL	43	AP	2019-10-07	STANDARD
LABELING; Labeling	SUPPL	44	AP	2021-04-28	STANDARD
LABELING; Labeling	SUPPL	45	AP	2021-04-28	STANDARD
LABELING; Labeling	SUPPL	49	AP	2016-12-16	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	35	Null	6
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	6
SUPPL	40	Null	6
SUPPL	41	Null	6
SUPPL	42	Null	7
SUPPL	43	Null	7
SUPPL	44	Null	15
SUPPL	45	Null	6

TE Codes

003

Prescription

AB

CDER Filings

ALLERGAN

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(
    [0] => Array
        (
            [ApplNo] => 19429
            [companyName] => ALLERGAN
            [docInserts] => ["Medication Guide",""]
            [products] => [{"drugName":"FIORINAL W\/CODEINE","activeIngredients":"ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE","strength":"325MG;50MG;40MG;30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/019429s043lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-43","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/019429s043lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019429s041s042lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-41","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019429s041s042lbl.pdf\"}]","notes":""},{"actionDate":"08\/29\/2017","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019429s040lbl.pdf\"}]","notes":""},{"actionDate":"08\/29\/2017","submission":"SUPPL-40","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019429s040lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-39","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019429s039lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019429s039lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019429s039lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2013","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019429s035lbl.pdf\"}]","notes":""},{"actionDate":"04\/08\/2008","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/019429s023lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"FIORINAL W\/CODEINE","submission":"ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE","actionType":"325MG;50MG;40MG;30MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-10-07
        )

)