ANDA 206218

TARO PHARMS

FDA Drug Application

Application #206218

Application Sponsors

ANDA 206218

TARO PHARMS

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

5%;1.2%

0

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-12-15

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

TARO PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206218
            [companyName] => TARO PHARMS
            [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":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/15\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-12-15
        )

)