CADILA PHARMS LTD FDA Approval ANDA 216212

ANDA 216212

CADILA PHARMS LTD

FDA Drug Application

Application #216212

Application Sponsors

ANDA 216212CADILA PHARMS LTD

Marketing Status

Prescription001
Prescription002

Application Products

001GRANULE;ORALEQ 200MG BASE/5ML0ERYTHROMYCIN ETHYLSUCCINATEERYTHROMYCIN ETHYLSUCCINATE
002GRANULE;ORALEQ 400MG BASE/5ML0ERYTHROMYCIN ETHYLSUCCINATEERYTHROMYCIN ETHYLSUCCINATE

FDA Submissions

UNKNOWN; ORIG1AP2022-11-21STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

CADILA PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216212
            [companyName] => CADILA PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ERYTHROMYCIN ETHYLSUCCINATE","activeIngredients":"ERYTHROMYCIN ETHYLSUCCINATE","strength":"EQ 200MG BASE\/5ML","dosageForm":"GRANULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ERYTHROMYCIN ETHYLSUCCINATE","activeIngredients":"ERYTHROMYCIN ETHYLSUCCINATE","strength":"EQ 400MG BASE\/5ML","dosageForm":"GRANULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/21\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-21
        )

)

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