Documents
Application Sponsors
ANDA 207961 | HETERO LABS LTD III | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | CAPSULE;ORAL | EQ 75MG BASE | 0 | DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE |
002 | CAPSULE;ORAL | EQ 150MG BASE | 0 | DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-05-06 | STANDARD |
UNKNOWN; | ORIG | 2 | TA | 2020-05-06 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
HETERO LABS LTD III
cder:Array
(
[0] => Array
(
[ApplNo] => 207961
[companyName] => HETERO LABS LTD III
[docInserts] => ["",""]
[products] => [{"drugName":"DABIGATRAN ETEXILATE MESYLATE","activeIngredients":"DABIGATRAN ETEXILATE MESYLATE","strength":"EQ 75MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DABIGATRAN ETEXILATE MESYLATE","activeIngredients":"DABIGATRAN ETEXILATE MESYLATE","strength":"EQ 150MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/06\/2020","submission":"ORIG-2","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/207961Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-05-06
)
)