NDA 019832

MYLAN INSTITUTIONAL

FDA Drug Application

Application #019832

Documents

• Letter: 1998-06-05
• Letter: 2001-07-12
• Letter: 2001-07-12
• Label: 1998-06-05
• Review: 1999-01-06

Application Sponsors

NDA 019832

MYLAN INSTITUTIONAL

Marketing Status

• Prescription: 003

Application Products

003

FOR SOLUTION;TOPICAL

5%

1

SULFAMYLON

MAFENIDE ACETATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1998-06-05	STANDARD
LABELING; Labeling	SUPPL	2	AP	2001-07-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2001-07-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2001-09-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2002-05-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2002-12-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2013-06-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2015-01-20	STANDARD

Submissions Property Types

ORIG	1	Null	25
SUPPL	3	Null	14
SUPPL	4	Null	14
SUPPL	5	Null	14
SUPPL	6	Null	14
SUPPL	13	Null	14
SUPPL	14	Null	14

TE Codes

003

Prescription

AT

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19832
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"SULFAMYLON","activeIngredients":"MAFENIDE ACETATE","strength":"5%","dosageForm":"FOR SOLUTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/05\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/19832lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SULFAMYLON","submission":"MAFENIDE ACETATE","actionType":"5%","submissionClassification":"FOR SOLUTION;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1998-06-05
        )

)