ANDA 209182

AM REGENT

FDA Drug Application

Application #209182

Application Sponsors

ANDA 209182

AM REGENT

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	2018-05-04	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-11-12	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209182
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEOSTIGMINE METHYLSULFATE","activeIngredients":"NEOSTIGMINE METHYLSULFATE","strength":"5MG\/10ML (0.5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NEOSTIGMINE METHYLSULFATE","activeIngredients":"NEOSTIGMINE METHYLSULFATE","strength":"10MG\/10ML (1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/04\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/12\/2021","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-11-12
        )

)