Documents
Application Sponsors
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
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
)
)