ANDA 214105

AMNEAL

FDA Drug Application

Application #214105

Application Sponsors

ANDA 214105

AMNEAL

Marketing Status

• Prescription: 001

Application Products

001

SPRAY, METERED;NASAL

0.5MG/SPRAY

0

DIHYDROERGOTAMINE MESYLATE

DIHYDROERGOTAMINE MESYLATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-01-04

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214105
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIHYDROERGOTAMINE MESYLATE","activeIngredients":"DIHYDROERGOTAMINE MESYLATE","strength":"0.5MG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/04\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-01-04
        )

)