Application Sponsors
ANDA 078863 | BIONPHARMA INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | INJECTABLE;INJECTION | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | 0 | GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE |
002 | INJECTABLE;INJECTION | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | 0 | GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE | GRANISETRON HYDROCHLORIDE |
FDA Submissions
Submissions Property Types
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
CDER Filings
BIONPHARMA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 78863
[companyName] => BIONPHARMA INC
[docInserts] => ["",""]
[products] => [{"drugName":"GRANISETRON HYDROCHLORIDE","activeIngredients":"GRANISETRON HYDROCHLORIDE","strength":"EQ 0.1MG BASE\/ML (EQ 0.1MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE","activeIngredients":"GRANISETRON HYDROCHLORIDE","strength":"EQ 1MG BASE\/ML (EQ 1MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"GRANISETRON HYDROCHLORIDE","submission":"GRANISETRON HYDROCHLORIDE","actionType":"EQ 0.1MG BASE\/ML (EQ 0.1MG BASE\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE","submission":"GRANISETRON HYDROCHLORIDE","actionType":"EQ 1MG BASE\/ML (EQ 1MG BASE\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)