NDA 213994

NEVAKAR INC

FDA Drug Application

Application #213994

Documents

• Letter: 2020-10-20
• Review: 2020-11-13
• Label: 2022-06-01

Application Sponsors

NDA 213994

NEVAKAR INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	5MG/ML	2	EPHEDRINE SULFATE	EPHEDRINE SULFATE
002	SOLUTION;INTRAVENOUS	25MG/5ML (5MG/ML)	1	EPHEDRINE SULFATE	EPHEDRINE SULFATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2020-10-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2022-04-22	N/A

Submissions Property Types

ORIG

1

Null

6

CDER Filings

NEVAKAR INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213994
            [companyName] => NEVAKAR INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"EPHEDRINE SULFATE","activeIngredients":"EPHEDRINE SULFATE","strength":"5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/16\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213994Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-16
        )

)