ANDA 209467

ZYDUS PHARMS

FDA Drug Application

Application #209467

Documents

• Letter: 2018-06-05

Application Sponsors

ANDA 209467

ZYDUS PHARMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

20MG/ML

0

SUCCINYLCHOLINE CHLORIDE

SUCCINYLCHOLINE CHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-05-04	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-04-06	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-03-04	STANDARD
LABELING; Labeling	SUPPL	7	AP	2022-02-09	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	5	Null	7
SUPPL	7	Null	15

TE Codes

001

Prescription

AP

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209467
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUCCINYLCHOLINE CHLORIDE","activeIngredients":"SUCCINYLCHOLINE CHLORIDE","strength":"20MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/04\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209467Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/06\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-04-06
        )

)