ANDA 090785

PERRIGO UK FINCO

FDA Drug Application

Application #090785

Documents

• Letter: 2010-04-05
• Review: 2012-11-14

Application Sponsors

ANDA 090785

PERRIGO UK FINCO

Marketing Status

• Prescription: 001

Application Products

001

AEROSOL, FOAM;TOPICAL

1%

0

CLINDAMYCIN PHOSPHATE

CLINDAMYCIN PHOSPHATE

FDA Submissions

	ORIG	1	AP	2010-03-31
LABELING; Labeling	SUPPL	2	AP	2012-11-30	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

TE Codes

001

Prescription

AT

CDER Filings

PERRIGO UK FINCO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90785
            [companyName] => PERRIGO UK FINCO
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLINDAMYCIN PHOSPHATE","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"1%","dosageForm":"AEROSOL, FOAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLINDAMYCIN PHOSPHATE","submission":"CLINDAMYCIN PHOSPHATE","actionType":"1%","submissionClassification":"AEROSOL, FOAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)