Application Sponsors
ANDA 202525 | WATSON LABS INC | |
Marketing Status
Application Products
001 | SOLUTION/DROPS;OPHTHALMIC | EQ 0.5% BASE | 0 | MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2015-03-06 | |
Submissions Property Types
TE Codes
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 202525
[companyName] => WATSON LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"MOXIFLOXACIN HYDROCHLORIDE","activeIngredients":"MOXIFLOXACIN HYDROCHLORIDE","strength":"EQ 0.5% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"03\/06\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"11\/27\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-11-27
)
)