ANDA 212907

CIPLA

FDA Drug Application

Application #212907

Documents

• Letter: 2020-06-08

Application Sponsors

ANDA 212907

CIPLA

Marketing Status

• Prescription: 001

Application Products

001

SPRAY, METERED;NASAL

0.5MG/SPRAY

0

DIHYDROERGOTAMINE MESYLATE

DIHYDROERGOTAMINE MESYLATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-05-20

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

CIPLA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212907
            [companyName] => CIPLA
            [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":"05\/20\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-20
        )

)