Application Sponsors
ANDA 204638 | MICRO LABS LTD INDIA | |
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | SOLUTION/DROPS;OPHTHALMIC | 0.01% | 0 | BIMATOPROST | BIMATOPROST |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2021-05-14 | |
Submissions Property Types
CDER Filings
MICRO LABS LTD INDIA
cder:Array
(
[0] => Array
(
[ApplNo] => 204638
[companyName] => MICRO LABS LTD INDIA
[docInserts] => ["",""]
[products] => [{"drugName":"BIMATOPROST","activeIngredients":"BIMATOPROST","strength":"0.01%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/14\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-05-14
)
)