ANDA 210191

TARO PHARMS

FDA Drug Application

Application #210191

Documents

• Letter: 2019-07-05

Application Sponsors

ANDA 210191

TARO PHARMS

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

7.5%

0

DAPSONE

DAPSONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-06-26

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

TARO PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210191
            [companyName] => TARO PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPSONE","activeIngredients":"DAPSONE","strength":"7.5%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/26\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210191Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-06-26
        )

)