ANDA 208258

TARO PHARMS

FDA Drug Application

Application #208258

Documents

• Label: 2017-04-05
• Letter: 2017-04-05

Application Sponsors

ANDA 208258

TARO PHARMS

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

0.1%

0

TAZAROTENE

TAZAROTENE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-04-03

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

TARO PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208258
            [companyName] => TARO PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TAZAROTENE","activeIngredients":"TAZAROTENE","strength":"0.1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/03\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208258Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/03\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208258Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208258Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2017-04-03
        )

)