DR REDDYS FDA Approval ANDA 210698

ANDA 210698

DR REDDYS

FDA Drug Application

Application #210698

Application Sponsors

ANDA 210698DR REDDYS

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION20MG/ML0SUCCINYLCHOLINE CHLORIDESUCCINYLCHOLINE CHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2019-08-02STANDARD
LABELING; LabelingSUPPL6AP2021-02-11STANDARD
LABELING; LabelingSUPPL7AP2021-10-25STANDARD
LABELING; LabelingSUPPL9AP2022-09-22STANDARD

Submissions Property Types

ORIG1Null15
SUPPL6Null15
SUPPL7Null7
SUPPL9Null7

TE Codes

001PrescriptionAP

CDER Filings

DR REDDYS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210698
            [companyName] => DR REDDYS
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUCCINYLCHOLINE CHLORIDE","activeIngredients":"SUCCINYLCHOLINE CHLORIDE","strength":"20MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/02\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-08-02
        )

)

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