ANDA 072265

EPIC PHARMA LLC

FDA Drug Application

Application #072265

Application Sponsors

ANDA 072265

EPIC PHARMA LLC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

1MG

0

BENZTROPINE MESYLATE

BENZTROPINE MESYLATE

FDA Submissions

	ORIG	1	AP	1989-02-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1995-12-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1995-12-01
LABELING; Labeling	SUPPL	4	AP	1995-12-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1995-12-01
LABELING; Labeling	SUPPL	6	AP	1998-05-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1998-10-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2001-01-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-01-11
LABELING; Labeling	SUPPL	12	AP	2003-01-09

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0

TE Codes

001

Prescription

AA

CDER Filings

EPIC PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72265
            [companyName] => EPIC PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENZTROPINE MESYLATE","activeIngredients":"BENZTROPINE MESYLATE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BENZTROPINE MESYLATE","submission":"BENZTROPINE MESYLATE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)