NDA 050793

PERRIGO PHARMA INTL

FDA Drug Application

Application #050793

Documents

• Letter: 2012-02-23
• Label: 2004-12-03
• Letter: 2004-12-06
• Letter: 2010-12-21
• Label: 2010-12-16
• Label: 2012-02-17
• Review: 2006-09-26

Application Sponsors

NDA 050793

PERRIGO PHARMA INTL

Marketing Status

• Prescription: 001

Application Products

001

CREAM;VAGINAL

EQ 2% BASE

1

CLINDESSE

CLINDAMYCIN PHOSPHATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2004-11-30	STANDARD
LABELING; Labeling	SUPPL	14	AP	2010-12-15	UNKNOWN
LABELING; Labeling	SUPPL	15	AP	2012-02-15	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2013-01-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2013-04-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2014-09-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2016-02-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2016-03-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2017-01-18	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	14	Null	7
SUPPL	15	Null	7
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0

CDER Filings

PERRIGO PHARMA INTL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50793
            [companyName] => PERRIGO PHARMA INTL
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLINDESSE","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 2% BASE","dosageForm":"CREAM;VAGINAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/15\/2012","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/050793s015lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/2010","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/050793s014lbl.pdf\"}]","notes":""},{"actionDate":"11\/30\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/050793lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CLINDESSE","submission":"CLINDAMYCIN PHOSPHATE","actionType":"EQ 2% BASE","submissionClassification":"CREAM;VAGINAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2012-02-15
        )

)