ANDA 212233

TULEX PHARMS INC

FDA Drug Application

Application #212233

Application Sponsors

ANDA 212233

TULEX PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

0.2MG

0

METHYLERGONOVINE MALEATE

METHYLERGONOVINE MALEATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-05-01

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

TULEX PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212233
            [companyName] => TULEX PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLERGONOVINE MALEATE","activeIngredients":"METHYLERGONOVINE MALEATE","strength":"0.2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-01
        )

)