ANDA 209506

TARO

FDA Drug Application

Application #209506

Documents

• Letter: 2017-10-18
• Label: 2017-10-18

Application Sponsors

ANDA 209506

TARO

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

5%

0

DAPSONE

DAPSONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-10-16

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209506
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPSONE","activeIngredients":"DAPSONE","strength":"5%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/16\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209506Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/16\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209506Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209506Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"09\/27\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-09-27
        )

)