Application Sponsors
ANDA 091626 | SUN PHARM INDS | |
Marketing Status
Application Products
001 | SOLUTION/DROPS;OPHTHALMIC | 0.05% | 0 | EPINASTINE HYDROCHLORIDE | EPINASTINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2011-10-31 | |
LABELING; Labeling | SUPPL | 4 | AP | 2016-01-21 | STANDARD |
Submissions Property Types
CDER Filings
SUN PHARM INDS
cder:Array
(
[0] => Array
(
[ApplNo] => 91626
[companyName] => SUN PHARM INDS
[docInserts] => ["",""]
[products] => [{"drugName":"EPINASTINE HYDROCHLORIDE","activeIngredients":"EPINASTINE HYDROCHLORIDE","strength":"0.05%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"EPINASTINE HYDROCHLORIDE","submission":"EPINASTINE HYDROCHLORIDE","actionType":"0.05%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)