NDA 017788

MYLAN INSTITUTIONAL

FDA Drug Application

Application #017788

Application Sponsors

NDA 017788

MYLAN INSTITUTIONAL

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVESICAL

50%

1

RIMSO-50

DIMETHYL SULFOXIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1978-04-04	STANDARD
LABELING; Labeling	SUPPL	2	AP	1980-09-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1988-10-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1989-02-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1989-09-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1995-03-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2000-05-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2008-07-28	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2013-06-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2014-08-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2015-08-27	STANDARD

Submissions Property Types

SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	16	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17788
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIMSO-50","activeIngredients":"DIMETHYL SULFOXIDE","strength":"50%","dosageForm":"SOLUTION;INTRAVESICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RIMSO-50","submission":"DIMETHYL SULFOXIDE","actionType":"50%","submissionClassification":"SOLUTION;INTRAVESICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)