Documents
Application Sponsors
NDA 214628 | NEVAKAR INJECTABLES, INC. | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | INJECTABLE;INJECTION | EQ 250ML BASE/ | 0 | NOREPINEPHRINE IN SODIUM CHLORIDE INJECTION | NOREPINEPHRINE IN SODIUM CHLORIDE |
002 | INJECTABLE;INJECTION | EQ 8MG BASE/250ML | 0 | NOREPINEPHRINE IN SODIUM CHLORIDE INJECTION | NOREPINEPHRINE IN SODIUM CHLORIDE |
003 | INJECTABLE;INJECTION | EQ 16MG BASE/250ML | 0 | NOREPINEPHRINE IN SODIUM CHLORIDE INJECTION | NOREPINEPHRINE IN SODIUM CHLORIDE |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2022-10-06 | STANDARD |
Submissions Property Types
CDER Filings
NEVAKAR INJECTABLES, INC.
cder:Array
(
[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
)
)