Documents
Application Sponsors
ANDA 208048 | DR REDDYS LABS LTD | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
None (Tentative Approval) | 003 |
Application Products
001 | CAPSULE;ORAL | EQ 75MG BASE | 0 | DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE |
002 | CAPSULE;ORAL | EQ 110MG BASE | 0 | DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE |
003 | CAPSULE;ORAL | EQ 150MG BASE | 0 | DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2020-10-26 | STANDARD |
Submissions Property Types
CDER Filings
DR REDDYS LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 208048
[companyName] => DR REDDYS LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"DABIGATRAN ETEXILATE MESYLATE","activeIngredients":"DABIGATRAN ETEXILATE MESYLATE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/26\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-10-26
)
)