SUN PHARM INDS FDA Approval ANDA 214319

ANDA 214319

SUN PHARM INDS

FDA Drug Application

Application #214319

Application Sponsors

ANDA 214319SUN PHARM INDS

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002

Application Products

002INJECTABLE;INJECTIONEQ 200MG BASE/2ML (EQ 100MG BASE/ML)0SUGAMMADEXSUGAMMADEX

FDA Submissions

UNKNOWN; ORIG1TA2022-05-10STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

SUN PHARM INDS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214319
            [companyName] => SUN PHARM INDS
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUGAMMADEX","activeIngredients":"SUGAMMADEX","strength":"EQ 500MG BASE\/5ML (EQ 100MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SUGAMMADEX","activeIngredients":"SUGAMMADEX","strength":"EQ 200MG BASE\/2ML (EQ 100MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/10\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-10
        )

)

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