ANDA 064126

PERRIGO CO

FDA Drug Application

Application #064126

Documents

• Review: 2011-03-10

Application Sponsors

ANDA 064126

PERRIGO CO

Marketing Status

• Prescription: 001

Application Products

001

SWAB;TOPICAL

2%

0

ERYTHROMYCIN

ERYTHROMYCIN

FDA Submissions

	ORIG	1	AP	1996-07-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-11-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-02-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2001-12-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2001-12-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2002-09-16
LABELING; Labeling	SUPPL	9	AP	2008-03-31

Submissions Property Types

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

TE Codes

001

Prescription

AT

CDER Filings

PERRIGO CO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 64126
            [companyName] => PERRIGO CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"ERYTHROMYCIN","activeIngredients":"ERYTHROMYCIN","strength":"2%","dosageForm":"SWAB;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ERYTHROMYCIN","submission":"ERYTHROMYCIN","actionType":"2%","submissionClassification":"SWAB;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)