DR REDDYS FDA Approval ANDA 216291

ANDA 216291

DR REDDYS

FDA Drug Application

Application #216291

Application Sponsors

ANDA 216291DR REDDYS

Marketing Status

Prescription001

Application Products

001SOLUTION;INTRAVENOUS3MG/ML (1MG/ML)0NEOSTIGMINE METHYLSULFATENEOSTIGMINE METHYLSULFATE

FDA Submissions

UNKNOWN; ORIG1AP2022-07-06STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

DR REDDYS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216291
            [companyName] => DR REDDYS
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEOSTIGMINE METHYLSULFATE","activeIngredients":"NEOSTIGMINE METHYLSULFATE","strength":"3MG\/ML (1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/06\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-06
        )

)

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