NDA 215143

HIKMA PHARMS

FDA Drug Application

Application #215143

Documents

• Label: 2021-08-22
• Letter: 2021-08-24
• Review: 2022-02-02
• Letter: 2022-03-18
• Label: 2022-04-05
• Letter: 2022-11-02
• Label: 2022-11-02

Application Sponsors

NDA 215143

HIKMA PHARMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MG/5ML

0

SUCCINYLCHOLINE CHLORIDE

SUCCINYLCHOLINE CHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2021-08-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	TA	2022-07-22	N/A
LABELING; Labeling	SUPPL	3	AP	2022-11-01	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7

CDER Filings

HIKMA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215143
            [companyName] => HIKMA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUCCINYLCHOLINE CHLORIDE","activeIngredients":"SUCCINYLCHOLINE CHLORIDE","strength":"100MG\/5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/20\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215143s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/20\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215143s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/215143Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-08-20
        )

)