Application Sponsors
NDA 078405 | SUN PHARMA GLOBAL | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 25MG/10ML (2.5MG/ML) | 0 | NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2009-11-17 | |
LABELING; Labeling | SUPPL | 6 | AP | 2014-09-16 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
SUN PHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 78405
[companyName] => SUN PHARM
[docInserts] => ["",""]
[products] => [{"drugName":"NICARDIPINE HYDROCHLORIDE","activeIngredients":"NICARDIPINE HYDROCHLORIDE","strength":"25MG\/10ML (2.5MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"NICARDIPINE HYDROCHLORIDE","submission":"NICARDIPINE HYDROCHLORIDE","actionType":"25MG\/10ML (2.5MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)