COREPHARMA FDA Approval ANDA 200263

ANDA 200263

COREPHARMA

FDA Drug Application

Application #200263

Application Sponsors

ANDA 200263COREPHARMA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORALEQ 25MG BASE0SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATE
002TABLET;ORALEQ 50MG BASE0SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATE
003TABLET;ORALEQ 100MG BASE0SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATE

FDA Submissions

N/A; Not ApplicableORIG1AP2012-06-19
LABELING; LabelingSUPPL2AP2020-07-16STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

COREPHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200263
            [companyName] => COREPHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUMATRIPTAN SUCCINATE","activeIngredients":"SUMATRIPTAN SUCCINATE","strength":"EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SUMATRIPTAN SUCCINATE","activeIngredients":"SUMATRIPTAN SUCCINATE","strength":"EQ 50MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SUMATRIPTAN SUCCINATE","activeIngredients":"SUMATRIPTAN SUCCINATE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/19\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/16\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/25\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-07-16
        )

)

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