Application Sponsors
ANDA 213210 | DR REDDYS LABS LTD | |
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | SOLUTION;INTRAVENOUS | 0.4MG/5ML (0.08MG/ML) | 0 | REGADENOSON | REGADENOSON |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2021-01-15 | UNKNOWN |
Submissions Property Types
TE Codes
CDER Filings
DR REDDYS LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 213210
[companyName] => DR REDDYS LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"REGADENOSON","activeIngredients":"REGADENOSON","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/15\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"UNKNOWN","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-01-15
)
)