ANDA 089060

PLIVA

FDA Drug Application

Application #089060

Application Sponsors

ANDA 089060

PLIVA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

2MG

0

BENZTROPINE MESYLATE

BENZTROPINE MESYLATE

FDA Submissions

	ORIG	1	AP	1988-08-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1992-09-24
BIOEQUIV; Bioequivalence	SUPPL	3	AP	1992-09-24
LABELING; Labeling	SUPPL	4	AP	1998-03-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1994-05-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1997-08-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1997-08-13
LABELING; Labeling	SUPPL	8	AP	1998-10-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2000-07-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2001-05-29
LABELING; Labeling	SUPPL	11	AP	2001-12-10

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	9	Null	0
SUPPL	10	Null	0

TE Codes

001

Prescription

AA

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89060
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENZTROPINE MESYLATE","activeIngredients":"BENZTROPINE MESYLATE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BENZTROPINE MESYLATE","submission":"BENZTROPINE MESYLATE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)