ANDA 211432

AMNEAL

FDA Drug Application

Application #211432

Application Sponsors

ANDA 211432

AMNEAL

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

20MG/ML

0

SUCCINYLCHOLINE CHLORIDE

SUCCINYLCHOLINE CHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-11-16	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-02-24	STANDARD
LABELING; Labeling	SUPPL	9	AP	2022-04-20	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	6	Null	7
SUPPL	9	Null	7

TE Codes

001

Prescription

AP

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211432
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUCCINYLCHOLINE CHLORIDE","activeIngredients":"SUCCINYLCHOLINE CHLORIDE","strength":"20MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/16\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-16
        )

)