ZYDUS PHARMS FDA Approval ANDA 208953

ANDA 208953

ZYDUS PHARMS

FDA Drug Application

Application #208953

Documents

Letter2018-12-20

Application Sponsors

ANDA 208953ZYDUS PHARMS

Marketing Status

Prescription001

Application Products

001SUPPOSITORY;RECTAL1GM0MESALAMINEMESALAMINE

FDA Submissions

UNKNOWN; ORIG1AP2020-02-12STANDARD
LABELING; LabelingSUPPL3AP2022-10-28STANDARD
LABELING; LabelingSUPPL5AP2022-10-28STANDARD

Submissions Property Types

ORIG1Null15
SUPPL3Null7
SUPPL5Null7

TE Codes

001PrescriptionAB

CDER Filings

ZYDUS PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208953
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MESALAMINE","activeIngredients":"MESALAMINE","strength":"1GM","dosageForm":"SUPPOSITORY;RECTAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/12\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208953Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-02-12
        )

)

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