ANDA 211483

AMNEAL PHARMS

FDA Drug Application

Application #211483

Documents

• Letter: 2018-12-20

Application Sponsors

ANDA 211483

AMNEAL PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

0.2MG

0

METHYLERGONOVINE MALEATE

METHYLERGONOVINE MALEATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-09-10

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

AMNEAL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211483
            [companyName] => AMNEAL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLERGONOVINE MALEATE","activeIngredients":"METHYLERGONOVINE MALEATE","strength":"0.2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/10\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/211483Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-09-10
        )

)