ANDA 090979

PERRIGO ISRAEL

FDA Drug Application

Application #090979

Application Sponsors

ANDA 090979

PERRIGO ISRAEL

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

5%;1.2%

0

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

FDA Submissions

	ORIG	1	AP	2012-06-26
LABELING; Labeling	SUPPL	3	AP	2015-05-18	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-09-03	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7
SUPPL	4	Null	7

TE Codes

001

Prescription

AB

CDER Filings

PERRIGO ISRAEL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90979
            [companyName] => PERRIGO ISRAEL
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE","activeIngredients":"BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","strength":"5%;1.2%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE","submission":"BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","actionType":"5%;1.2%","submissionClassification":"GEL;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)