NDA 019594

ALLERGAN

FDA Drug Application

Application #019594

Documents

• Letter: 2002-08-14
• Label: 2018-01-11

Application Sponsors

NDA 019594

ALLERGAN

Marketing Status

• Discontinued: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	150MG	0	ACTIGALL	URSODIOL
002	CAPSULE;ORAL	300MG	1	ACTIGALL	URSODIOL

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1987-12-31	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1988-07-08	PRIORITY
LABELING; Labeling	SUPPL	3	AP	1988-07-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1988-10-26	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1988-09-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1989-04-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1989-08-02	PRIORITY
LABELING; Labeling	SUPPL	8	AP	1989-05-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1991-10-04	PRIORITY
LABELING; Labeling	SUPPL	10	AP	1990-10-05
LABELING; Labeling	SUPPL	11	AP	1992-04-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2002-03-15	PRIORITY
EFFICACY; Efficacy	SUPPL	16	AP	1996-03-29	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1995-09-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1996-06-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1999-04-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1999-04-22	PRIORITY
LABELING; Labeling	SUPPL	21	AP	2002-08-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2015-10-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	2016-06-27	PRIORITY

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	2	Null	14
SUPPL	4	Null	14
SUPPL	5	Null	14
SUPPL	6	Null	14
SUPPL	7	Null	14
SUPPL	9	Null	14
SUPPL	13	Null	14
SUPPL	17	Null	14
SUPPL	18	Null	14
SUPPL	19	Null	14
SUPPL	20	Null	14
SUPPL	34	Null	14
SUPPL	35	Null	14

TE Codes

002

Prescription

AB

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19594
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACTIGALL","activeIngredients":"URSODIOL","strength":"150MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ACTIGALL","activeIngredients":"URSODIOL","strength":"300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/14\/2002","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019594s21lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ACTIGALL","submission":"URSODIOL","actionType":"150MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ACTIGALL","submission":"URSODIOL","actionType":"300MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2002-08-14
        )

)