ANDA 089074

PERRIGO CO

FDA Drug Application

Application #089074

Application Sponsors

ANDA 089074

PERRIGO CO

Marketing Status

• Prescription: 001

Application Products

001

LOTION;TOPICAL

2.5%

0

STIE-CORT

HYDROCORTISONE

FDA Submissions

	ORIG	1	AP	1985-11-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-05-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-04-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1995-09-14
LABELING; Labeling	SUPPL	8	AP	1995-09-14
LABELING; Labeling	SUPPL	9	AP	1996-01-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1996-01-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1995-04-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1995-09-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1998-08-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2001-08-16
LABELING; Labeling	SUPPL	15	AP	2007-11-28

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	7	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0

TE Codes

001

Prescription

AT

CDER Filings

PERRIGO CO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89074
            [companyName] => PERRIGO CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"STIE-CORT","activeIngredients":"HYDROCORTISONE","strength":"2.5%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"STIE-CORT","submission":"HYDROCORTISONE","actionType":"2.5%","submissionClassification":"LOTION;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)