ANDA 212968

GLAND PHARMA LTD

FDA Drug Application

Application #212968

Application Sponsors

ANDA 212968

GLAND PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;INTRAVENOUS	5MG/10ML (0.5MG/ML)	0	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE
002	SOLUTION;INTRAVENOUS	10MG/10ML (1MG/ML)	0	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-10-16

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212968
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEOSTIGMINE METHYLSULFATE","activeIngredients":"NEOSTIGMINE METHYLSULFATE","strength":"5MG\/10ML (0.5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NEOSTIGMINE METHYLSULFATE","activeIngredients":"NEOSTIGMINE METHYLSULFATE","strength":"10MG\/10ML (1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/16\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-10-16
        )

)