UMEDICA LABS PVT LTD FDA Approval ANDA 213853

ANDA 213853

UMEDICA LABS PVT LTD

FDA Drug Application

Application #213853

Application Sponsors

ANDA 213853UMEDICA LABS PVT LTD

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORALEQ 10MG BASE0ATORVASTATIN CALCIUMATORVASTATIN CALCIUM
002TABLET;ORALEQ 20MG BASE0ATORVASTATIN CALCIUMATORVASTATIN CALCIUM
003TABLET;ORALEQ 40MG BASE0ATORVASTATIN CALCIUMATORVASTATIN CALCIUM
004TABLET;ORALEQ 80MG BASE0ATORVASTATIN CALCIUMATORVASTATIN CALCIUM

FDA Submissions

UNKNOWN; ORIG1AP2020-08-19STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

UMEDICA LABS PVT LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213853
            [companyName] => UMEDICA LABS PVT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATORVASTATIN CALCIUM","activeIngredients":"ATORVASTATIN CALCIUM","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATORVASTATIN CALCIUM","activeIngredients":"ATORVASTATIN CALCIUM","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATORVASTATIN CALCIUM","activeIngredients":"ATORVASTATIN CALCIUM","strength":"EQ 40MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATORVASTATIN CALCIUM","activeIngredients":"ATORVASTATIN CALCIUM","strength":"EQ 80MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/19\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-19
        )

)

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