NEVAKAR INJECTABLES, INC. FDA Approval NDA 214628

NDA 214628

NEVAKAR INJECTABLES, INC.

FDA Drug Application

Application #214628

Documents

Letter2022-10-07

Application Sponsors

NDA 214628NEVAKAR INJECTABLES, INC.

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001INJECTABLE;INJECTIONEQ 250ML BASE/0NOREPINEPHRINE IN SODIUM CHLORIDE INJECTIONNOREPINEPHRINE IN SODIUM CHLORIDE
002INJECTABLE;INJECTIONEQ 8MG BASE/250ML0NOREPINEPHRINE IN SODIUM CHLORIDE INJECTIONNOREPINEPHRINE IN SODIUM CHLORIDE
003INJECTABLE;INJECTIONEQ 16MG BASE/250ML0NOREPINEPHRINE IN SODIUM CHLORIDE INJECTIONNOREPINEPHRINE IN SODIUM CHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2022-10-06STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

NEVAKAR INJECTABLES, INC.
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    [0] => Array
        (
            [ApplNo] => 214628
            [companyName] => NEVAKAR INJECTABLES, INC.
            [docInserts] => ["",""]
            [products] => [{"drugName":"NOREPINEPHRINE IN SODIUM CHLORIDE INJECTION","activeIngredients":"NOREPINEPHRINE IN SODIUM CHLORIDE","strength":"EQ 250ML BASE\/","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"NOREPINEPHRINE IN SODIUM CHLORIDE INJECTION","activeIngredients":"NOREPINEPHRINE IN SODIUM CHLORIDE","strength":"EQ 8MG BASE\/250ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"NOREPINEPHRINE IN SODIUM CHLORIDE INJECTION","activeIngredients":"NOREPINEPHRINE IN SODIUM CHLORIDE","strength":"EQ 16MG BASE\/250ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/06\/2022","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\\\/2022\\\/214628Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-06
        )

)

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