SUN PHARM INDS LTD FDA Approval ANDA 076572

ANDA 076572

SUN PHARM INDS LTD

FDA Drug Application

Application #076572

Documents

Letter2009-02-13

Application Sponsors

ANDA 076572SUN PHARM INDS LTD

Marketing Status

Prescription001

Application Products

001TABLET;ORALEQ 100MG BASE0SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATE

FDA Submissions

ORIG1AP2009-02-09
LABELING; LabelingSUPPL2AP2011-02-18
LABELING; LabelingSUPPL3AP2012-08-10STANDARD
LABELING; LabelingSUPPL4AP2015-11-23STANDARD
LABELING; LabelingSUPPL8AP2020-07-20STANDARD

Submissions Property Types

SUPPL2Null7
SUPPL3Null15
SUPPL4Null15
SUPPL8Null15

TE Codes

001PrescriptionAB

CDER Filings

SUN PHARM INDS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76572
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUMATRIPTAN SUCCINATE","activeIngredients":"SUMATRIPTAN SUCCINATE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SUMATRIPTAN SUCCINATE","submission":"SUMATRIPTAN SUCCINATE","actionType":"EQ 100MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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