ZYDUS PHARMS FDA Approval ANDA 208303

ANDA 208303

ZYDUS PHARMS

FDA Drug Application

Application #208303

Application Sponsors

ANDA 208303ZYDUS PHARMS

Marketing Status

Prescription001

Application Products

001TABLET;ORAL500MCG0ROFLUMILASTROFLUMILAST

FDA Submissions

UNKNOWN; ORIG1AP2022-02-10STANDARD
UNKNOWN; ORIG2TA2022-02-10STANDARD

Submissions Property Types

ORIG1Null15
ORIG2Null31

TE Codes

001PrescriptionAB

CDER Filings

ZYDUS PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208303
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROFLUMILAST","activeIngredients":"ROFLUMILAST","strength":"500MCG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/10\/2022","submission":"ORIG-2","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/10\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-10
        )

)

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