PAR PHARM INC FDA Approval ANDA 211991

ANDA 211991

PAR PHARM INC

FDA Drug Application

Application #211991

Documents

Letter2019-12-03

Application Sponsors

ANDA 211991PAR PHARM INC

Marketing Status

Prescription001
Prescription002

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2019-10-23STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

PAR PHARM INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211991
            [companyName] => PAR PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ERYTHROMYCIN ETHYLSUCCINATE","activeIngredients":"ERYTHROMYCIN ETHYLSUCCINATE","strength":"EQ 200MG BASE\/5ML","dosageForm":"GRANULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ERYTHROMYCIN ETHYLSUCCINATE","activeIngredients":"ERYTHROMYCIN ETHYLSUCCINATE","strength":"EQ 400MG BASE\/5ML","dosageForm":"GRANULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/23\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211991Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-10-23
        )

)

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