Documents
Application Sponsors
ANDA 210502 | DR REDDYS LABS LTD | |
Marketing Status
None (Tentative Approval) | 001 |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2020-07-30 | STANDARD |
Submissions Property Types
CDER Filings
DR REDDYS LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 210502
[companyName] => DR REDDYS LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE","activeIngredients":"CANAGLIFLOZIN;METFORMIN HYDROCHLORIDE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/30\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-07-30
)
)