ANDA 074625

UPSHER SMITH LABS

FDA Drug Application

Application #074625

Application Sponsors

ANDA 074625

UPSHER SMITH LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

5MG

0

OXYBUTYNIN CHLORIDE

OXYBUTYNIN CHLORIDE

FDA Submissions

	ORIG	1	AP	1996-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1996-10-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1999-01-08
LABELING; Labeling	SUPPL	10	AP	2006-12-17
LABELING; Labeling	SUPPL	14	AP	2009-01-06
LABELING; Labeling	SUPPL	17	AP	2010-03-03
LABELING; Labeling	SUPPL	21	AP	2012-04-26
LABELING; Labeling	SUPPL	22	AP	2012-04-26
LABELING; Labeling	SUPPL	23	AP	2013-07-31	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	17	Null	7
SUPPL	21	Null	15
SUPPL	22	Null	8
SUPPL	23	Null	15

TE Codes

001

Prescription

AB

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74625
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYBUTYNIN CHLORIDE","activeIngredients":"OXYBUTYNIN CHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OXYBUTYNIN CHLORIDE","submission":"OXYBUTYNIN CHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)