Application Sponsors
ANDA 216496 | MANKIND PHARMA | |
Marketing Status
Application Products
001 | SOLUTION/DROPS;OPHTHALMIC | 10% | 0 | PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2023-01-11 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
MANKIND PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 216496
[companyName] => MANKIND PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"PHENYLEPHRINE HYDROCHLORIDE","activeIngredients":"PHENYLEPHRINE HYDROCHLORIDE","strength":"10%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/11\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2023-01-11
)
)