ANDA 089452

MIKART

FDA Drug Application

Application #089452

Application Sponsors

ANDA 089452

MIKART

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

35MG

0

PHENDIMETRAZINE TARTRATE

PHENDIMETRAZINE TARTRATE

FDA Submissions

	ORIG	1	AP	1991-10-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1998-02-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-02-17
LABELING; Labeling	SUPPL	4	AP	1998-10-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-05-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2001-08-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-08-13
LABELING; Labeling	SUPPL	15	AP	2013-07-02	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	15	Null	15

TE Codes

001

Prescription

AA

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89452
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENDIMETRAZINE TARTRATE","activeIngredients":"PHENDIMETRAZINE TARTRATE","strength":"35MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PHENDIMETRAZINE TARTRATE","submission":"PHENDIMETRAZINE TARTRATE","actionType":"35MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)