Documents
Application Sponsors
Marketing Status
None (Tentative Approval) | 001 |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2022-02-23 | STANDARD |
Submissions Property Types
CDER Filings
APOTEX INC
cder:Array
(
[0] => Array
(
[ApplNo] => 207334
[companyName] => APOTEX INC
[docInserts] => ["",""]
[products] => [{"drugName":"BROMFENAC","activeIngredients":"BROMFENAC","strength":"0.07%","dosageForm":"SOLUTION; OPHTHALMIC","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/23\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-02-23
)
)