Application Sponsors
| ANDA 090664 | MYLAN INSTITUTIONAL | |
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 | 2 | AP | 2011-12-31 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2020-05-27 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2020-05-27 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 7 |
CDER Filings
MYLAN INSTITUTIONAL
cder:Array
(
[0] => Array
(
[ApplNo] => 90664
[companyName] => MYLAN INSTITUTIONAL
[docInserts] => ["",""]
[products] => [{"drugName":"NICARDIPINE HYDROCHLORIDE","activeIngredients":"NICARDIPINE HYDROCHLORIDE","strength":"25MG\/10ML (2.5MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"NICARDIPINE HYDROCHLORIDE","submission":"NICARDIPINE HYDROCHLORIDE","actionType":"25MG\/10ML (2.5MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)