NDA 016763

MYLAN INSTITUTIONAL

FDA Drug Application

Application #016763

Application Sponsors

NDA 016763

MYLAN INSTITUTIONAL

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

EQ 85MG BASE/GM

1

SULFAMYLON

MAFENIDE ACETATE

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	1969-01-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1977-01-26	PRIORITY
LABELING; Labeling	SUPPL	15	AP	1976-07-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1977-01-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1983-05-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1980-07-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1981-04-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1983-11-03	PRIORITY
LABELING; Labeling	SUPPL	22	AP	1983-08-24
LABELING; Labeling	SUPPL	23	AP	1984-12-11
LABELING; Labeling	SUPPL	25	AP	1988-11-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1988-03-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1990-12-04	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1994-09-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1994-10-14	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1998-04-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1999-01-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2000-08-31	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2002-12-13	PRIORITY

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	14	Null	14
SUPPL	16	Null	14
SUPPL	18	Null	14
SUPPL	19	Null	14
SUPPL	20	Null	14
SUPPL	21	Null	14
SUPPL	26	Null	14
SUPPL	28	Null	14
SUPPL	29	Null	14
SUPPL	30	Null	14
SUPPL	31	Null	14
SUPPL	32	Null	14
SUPPL	33	Null	14
SUPPL	34	Null	14

CDER Filings

RISING

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16763
            [companyName] => RISING
            [docInserts] => ["",""]
            [products] => [{"drugName":"SULFAMYLON","activeIngredients":"MAFENIDE ACETATE","strength":"EQ 85MG BASE\/GM","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SULFAMYLON","submission":"MAFENIDE ACETATE","actionType":"EQ 85MG BASE\/GM","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)