ANDA 212046

APOLLO

FDA Drug Application

Application #212046

Application Sponsors

ANDA 212046

APOLLO

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1MG/ML

0

DIHYDROERGOTAMINE MESYLATE

DIHYDROERGOTAMINE MESYLATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-01-07

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

APOLLO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212046
            [companyName] => APOLLO
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIHYDROERGOTAMINE MESYLATE","activeIngredients":"DIHYDROERGOTAMINE MESYLATE","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/07\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-01-07
        )

)