ANDA 075153

L PERRIGO CO

FDA Drug Application

Application #075153

Documents

• Letter: 1999-02-26

Application Sponsors

ANDA 075153

L PERRIGO CO

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

120MG

0

PSEUDOEPHEDRINE HYDROCHLORIDE

PSEUDOEPHEDRINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1999-02-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2001-04-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2001-04-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2002-05-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2002-05-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-10-22
LABELING; Labeling	SUPPL	8	AP	2001-12-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2002-12-09
LABELING; Labeling	SUPPL	17	AP	2005-04-20
LABELING; Labeling	SUPPL	34	AP	2011-05-24

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0

CDER Filings

L PERRIGO CO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75153
            [companyName] => L PERRIGO CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"PSEUDOEPHEDRINE HYDROCHLORIDE","activeIngredients":"PSEUDOEPHEDRINE HYDROCHLORIDE","strength":"120MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PSEUDOEPHEDRINE HYDROCHLORIDE","submission":"PSEUDOEPHEDRINE HYDROCHLORIDE","actionType":"120MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)