ANDA 075232

L PERRIGO CO

FDA Drug Application

Application #075232

Documents

• Label: 2000-01-06
• Letter: 2000-01-06
• Review: 2001-12-28

Application Sponsors

ANDA 075232

L PERRIGO CO

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

2MG

0

LOPERAMIDE HYDROCHLORIDE

LOPERAMIDE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2000-01-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-10-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-10-04
LABELING; Labeling	SUPPL	4	AP	2002-10-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2002-10-04
LABELING; Labeling	SUPPL	6	AP	2002-10-04
LABELING; Labeling	SUPPL	20	AP	2007-10-23
LABELING; Labeling	SUPPL	44	AP	2020-06-08	STANDARD
LABELING; Labeling	SUPPL	46	AP	2020-06-08	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	44	Null	15
SUPPL	46	Null	15

CDER Filings

L PERRIGO CO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75232
            [companyName] => L PERRIGO CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOPERAMIDE HYDROCHLORIDE","activeIngredients":"LOPERAMIDE HYDROCHLORIDE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/06\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2000\\\/75-232_Loperamide_prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LOPERAMIDE HYDROCHLORIDE","submission":"LOPERAMIDE HYDROCHLORIDE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2000-01-06
        )

)