ANDA 081265

CHARTWELL RX

FDA Drug Application

Application #081265

Application Sponsors

ANDA 081265

CHARTWELL RX

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	2MG	0	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE
002	TABLET;ORAL	1MG	0	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE

FDA Submissions

	ORIG	1	AP	1992-01-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1994-01-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1995-06-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1996-10-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1997-02-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1997-12-05
LABELING; Labeling	SUPPL	7	AP	1998-03-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2000-05-16
LABELING; Labeling	SUPPL	10	AP	2002-05-15

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0

TE Codes

001	Prescription	AA
002	Prescription	AA

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 81265
            [companyName] => CHARTWELL RX
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENZTROPINE MESYLATE","activeIngredients":"BENZTROPINE MESYLATE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BENZTROPINE MESYLATE","activeIngredients":"BENZTROPINE MESYLATE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BENZTROPINE MESYLATE","submission":"BENZTROPINE MESYLATE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BENZTROPINE MESYLATE","submission":"BENZTROPINE MESYLATE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)