NDA 020675

ALLERGAN

FDA Drug Application

Application #020675

Documents

• Letter: 2001-03-08
• Letter: 2008-03-13
• Label: 2008-03-13
• Label: 2009-12-02
• Review: 1997-12-10
• Letter: 2001-03-08
• Letter: 2004-07-28
• Letter: 2004-09-29
• Letter: 2013-06-18
• Label: 2004-07-28
• Label: 2013-06-18
• Letter: 2021-05-11
• Label: 2021-05-12
• Letter: 2023-01-13
• Label: 2023-01-13

Application Sponsors

NDA 020675

ALLERGAN

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	250MG	1	URSO 250	URSODIOL
002	TABLET;ORAL	500MG	1	URSO FORTE	URSODIOL

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1997-12-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2001-02-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-02-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2001-01-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2001-03-08	STANDARD
LABELING; Labeling	SUPPL	7	AP	2001-03-08	STANDARD
EFFICACY; Efficacy	SUPPL	9	AP	2004-07-21	STANDARD
LABELING; Labeling	SUPPL	11	AP	2004-09-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2008-03-10	N/A
LABELING; Labeling	SUPPL	17	AP	2009-11-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2013-02-27	STANDARD
LABELING; Labeling	SUPPL	22	AP	2013-06-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2013-08-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2013-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2013-09-11	STANDARD
LABELING; Labeling	SUPPL	27	AP	2021-05-07	STANDARD
LABELING; Labeling	SUPPL	28	AP	2023-01-12	STANDARD

Submissions Property Types

ORIG	1	Null	25
SUPPL	2	Null	14
SUPPL	4	Null	14
SUPPL	5	Null	14
SUPPL	6	Null	14
SUPPL	17	Null	6
SUPPL	21	Null	14
SUPPL	22	Null	7
SUPPL	23	Null	14
SUPPL	24	Null	14
SUPPL	25	Null	14
SUPPL	27	Null	6
SUPPL	28	Null	6

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20675
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"URSO 250","activeIngredients":"URSODIOL","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"URSO FORTE","activeIngredients":"URSODIOL","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/14\/2013","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020675s022lbl.pdf\"}]","notes":""},{"actionDate":"11\/25\/2009","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020675s017lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2008","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020675s013lbl.pdf\"}]","notes":""},{"actionDate":"07\/21\/2004","submission":"SUPPL-9","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20675s009lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"URSO 250","submission":"URSODIOL","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"URSO FORTE","submission":"URSODIOL","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2013-06-14
        )

)