Application Sponsors
ANDA 202963 | DR REDDYS LABS LTD | |
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 3.5MG/VIAL | 0 | BORTEZOMIB | BORTEZOMIB |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2019-06-25 | |
Submissions Property Types
TE Codes
CDER Filings
DR REDDYS LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 202963
[companyName] => DR REDDYS LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"BORTEZOMIB","activeIngredients":"BORTEZOMIB","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/25\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-06-25
)
)