CAPLIN FDA Approval ANDA 213998

ANDA 213998

CAPLIN

FDA Drug Application

Application #213998

Application Sponsors

ANDA 213998CAPLIN

Marketing Status

Prescription001

Application Products

001INJECTABLE;SUBCUTANEOUSEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)0SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATE

FDA Submissions

UNKNOWN; ORIG1AP2021-07-13STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

CAPLIN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213998
            [companyName] => CAPLIN
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUMATRIPTAN SUCCINATE","activeIngredients":"SUMATRIPTAN SUCCINATE","strength":"EQ 6MG BASE\/0.5ML (EQ 12MG BASE\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/13\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-07-13
        )

)

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