ANDA 206575

TARO

FDA Drug Application

Application #206575

Documents

• Letter: 2018-07-06

Application Sponsors

ANDA 206575

TARO

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

2019-08-19

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206575
            [companyName] => TARO
            [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":"08\/19\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/206575Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-08-19
        )

)