ANDA 214308

INDOCO REMEDIES

FDA Drug Application

Application #214308

Application Sponsors

ANDA 214308

INDOCO REMEDIES

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

20MG/ML

0

SUCCINYLCHOLINE CHLORIDE

SUCCINYLCHOLINE CHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-05-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2020-11-05	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-10-29	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	4	Null	15

TE Codes

001

Prescription

AP

CDER Filings

INDOCO REMEDIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214308
            [companyName] => INDOCO REMEDIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUCCINYLCHOLINE CHLORIDE","activeIngredients":"SUCCINYLCHOLINE CHLORIDE","strength":"20MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/22\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-22
        )

)