UMEDICA LABS PVT LTD FDA Approval ANDA 209302

ANDA 209302

UMEDICA LABS PVT LTD

FDA Drug Application

Application #209302

Application Sponsors

ANDA 209302UMEDICA LABS PVT LTD

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORALEQ 50MG BASE0SILDENAFIL CITRATESILDENAFIL CITRATE
002TABLET;ORALEQ 100MG BASE0SILDENAFIL CITRATESILDENAFIL CITRATE

FDA Submissions

UNKNOWN; ORIG1AP2020-08-25STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

UMEDICA LABS PVT LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209302
            [companyName] => UMEDICA LABS PVT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SILDENAFIL CITRATE","activeIngredients":"SILDENAFIL CITRATE","strength":"EQ 50MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SILDENAFIL CITRATE","activeIngredients":"SILDENAFIL CITRATE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/25\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-25
        )

)

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