ANDA 207631

ANI PHARMS INC

FDA Drug Application

Application #207631

Documents

• Letter: 2016-07-19
• Label: 2016-07-21
• Review: 2020-05-08

Application Sponsors

ANDA 207631

ANI PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

150MG

0

NILUTAMIDE

NILUTAMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-07-15

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

ANI PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207631
            [companyName] => ANI PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NILUTAMIDE","activeIngredients":"NILUTAMIDE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/15\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/207631Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/15\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/207631Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/207631Orig1s000ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/207631Orig1s000.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"09\/04\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-09-04
        )

)