ANDA 205961

AMNEAL PHARMS NY

FDA Drug Application

Application #205961

Documents

• Letter: 2018-07-06

Application Sponsors

ANDA 205961

AMNEAL PHARMS NY

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-06-19

STANDARD

Submissions Property Types

ORIG

1

Null

1

CDER Filings

AMNEAL PHARMS NY

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205961
            [companyName] => AMNEAL PHARMS NY
            [docInserts] => ["",""]
            [products] => [{"drugName":"PITAVASTATIN","activeIngredients":"PITAVASTATIN","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PITAVASTATIN","activeIngredients":"PITAVASTATIN","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PITAVASTATIN","activeIngredients":"PITAVASTATIN","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/19\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205961Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-06-19
        )

)