ANDA 211393

CUSTOPHARM INC

FDA Drug Application

Application #211393

Documents

• Letter: 2020-03-17

Application Sponsors

ANDA 211393

CUSTOPHARM INC

Marketing Status

• Prescription: 001

Application Products

001

SPRAY, METERED;NASAL

0.5MG/SPRAY

0

DIHYDROERGOTAMINE MESYLATE

DIHYDROERGOTAMINE MESYLATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-02-28

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

CUSTOPHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211393
            [companyName] => CUSTOPHARM INC
            [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":"02\/28\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211393Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-02-28
        )

)