ANDA 205397

PERRIGO ISRAEL

FDA Drug Application

Application #205397

Documents

• Letter: 2017-10-13

Application Sponsors

ANDA 205397

PERRIGO ISRAEL

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

2.5%;EQ 1.2% BASE

0

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-09-09

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

PERRIGO ISRAEL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205397
            [companyName] => PERRIGO ISRAEL
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE","activeIngredients":"BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","strength":"2.5%;EQ 1.2% BASE","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/09\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205397Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-09-09
        )

)