ANDA 202440

PERRIGO UK FINCO

FDA Drug Application

Application #202440

Documents

• Letter: 2015-09-23

Application Sponsors

ANDA 202440

PERRIGO UK FINCO

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

5%;EQ 1% BASE

0

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2015-09-21

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

PERRIGO UK FINCO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202440
            [companyName] => PERRIGO UK FINCO
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE","activeIngredients":"BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","strength":"5%;EQ 1% BASE","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/21\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/202440Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-09-21
        )

)