Application Sponsors
ANDA 202951 | EMCURE PHARMS LTD | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | INJECTABLE;INTRAVENOUS | EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) | 0 | PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE |
002 | INJECTABLE;INTRAVENOUS | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | 0 | PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2021-06-29 | |
Submissions Property Types
TE Codes
CDER Filings
EMCURE PHARMS LTD
cder:Array
(
[0] => Array
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[ApplNo] => 202951
[companyName] => EMCURE PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"PALONOSETRON HYDROCHLORIDE","activeIngredients":"PALONOSETRON HYDROCHLORIDE","strength":"EQ 0.075MG BASE\/1.5ML (EQ 0.05MG BASE\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PALONOSETRON HYDROCHLORIDE","activeIngredients":"PALONOSETRON HYDROCHLORIDE","strength":"EQ 0.25MG BASE\/5ML (EQ 0.05MG BASE\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/29\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-06-29
)
)