Application Sponsors
ANDA 204059 | BAYSHORE PHARMS LLC | |
Marketing Status
Application Products
001 | SOLUTION/DROPS;OPHTHALMIC | EQ 0.025% BASE | 0 | KETOTIFEN FUMARATE | KETOTIFEN FUMARATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-06-01 | |
Submissions Property Types
CDER Filings
BAYSHORE PHARMS LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 204059
[companyName] => BAYSHORE PHARMS LLC
[docInserts] => ["",""]
[products] => [{"drugName":"KETOTIFEN FUMARATE","activeIngredients":"KETOTIFEN FUMARATE","strength":"EQ 0.025% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-06-01
)
)