AMRING PHARMS FDA Approval ANDA 210231

ANDA 210231

AMRING PHARMS

FDA Drug Application

Application #210231

Application Sponsors

ANDA 210231AMRING PHARMS

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION20MG/ML0SUCCINYLCHOLINE CHLORIDESUCCINYLCHOLINE CHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2018-06-04STANDARD
LABELING; LabelingSUPPL2AP2020-02-10STANDARD
LABELING; LabelingSUPPL3AP2020-02-10STANDARD
LABELING; LabelingSUPPL4AP2020-10-15STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null7
SUPPL3Null7
SUPPL4Null15

TE Codes

001PrescriptionAP

CDER Filings

AMRING PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210231
            [companyName] => AMRING PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUCCINYLCHOLINE CHLORIDE","activeIngredients":"SUCCINYLCHOLINE CHLORIDE","strength":"20MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/04\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/15\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/10\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/10\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-10-15
        )

)

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