Application Sponsors
Marketing Status
Application Products
001 | SOLUTION/DROPS;OPHTHALMIC | 0.5% | 0 | GATIFLOXACIN | GATIFLOXACIN |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2021-11-03 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
TORRENT
cder:Array
(
[0] => Array
(
[ApplNo] => 213542
[companyName] => TORRENT
[docInserts] => ["",""]
[products] => [{"drugName":"GATIFLOXACIN","activeIngredients":"GATIFLOXACIN","strength":"0.5%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/03\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-11-03
)
)