ANDA 073254

CONTRACT PHARMACAL

FDA Drug Application

Application #073254

Application Sponsors

ANDA 073254

CONTRACT PHARMACAL

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

2MG

0

LOPERAMIDE HYDROCHLORIDE

LOPERAMIDE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1993-07-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1994-05-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1995-07-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1994-08-30
LABELING; Labeling	SUPPL	5	AP	1996-02-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1996-02-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1996-08-26
LABELING; Labeling	SUPPL	8	AP	1998-03-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1999-08-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2000-09-21

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0

CDER Filings

CONTRACT PHARMACAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 73254
            [companyName] => CONTRACT PHARMACAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOPERAMIDE HYDROCHLORIDE","activeIngredients":"LOPERAMIDE HYDROCHLORIDE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LOPERAMIDE HYDROCHLORIDE","submission":"LOPERAMIDE HYDROCHLORIDE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)