ANDA 062840

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #062840

Application Sponsors

ANDA 062840

ACTAVIS MID ATLANTIC

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;TOPICAL

100,000 UNITS/GM

0

NYSTATIN

NYSTATIN

FDA Submissions

	ORIG	1	AP	1987-11-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1988-05-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1992-05-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1994-10-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1995-06-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1995-10-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1995-10-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1998-06-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2000-01-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2001-05-30

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0

TE Codes

001

Prescription

AT

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62840
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NYSTATIN","activeIngredients":"NYSTATIN","strength":"100,000 UNITS\/GM","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NYSTATIN","submission":"NYSTATIN","actionType":"100,000 UNITS\/GM","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)