ANDA 216291

DR REDDYS

FDA Drug Application

Application #216291

Documents

• Letter: 2022-08-30

Application Sponsors

ANDA 216291

DR REDDYS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

3MG/ML (1MG/ML)

0

NEOSTIGMINE METHYLSULFATE

NEOSTIGMINE METHYLSULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-07-06

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

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
        )

)