Application Sponsors
| ANDA 205740 | HETERO LABS LTD V | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 0.5MG | 0 | ENTECAVIR | ENTECAVIR |
| 002 | TABLET;ORAL | 1MG | 0 | ENTECAVIR | ENTECAVIR |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2015-08-21 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2019-05-31 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2019-05-31 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
HETERO LABS LTD V
cder:Array
(
[0] => Array
(
[ApplNo] => 205740
[companyName] => HETERO LABS LTD V
[docInserts] => ["",""]
[products] => [{"drugName":"ENTECAVIR","activeIngredients":"ENTECAVIR","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ENTECAVIR","activeIngredients":"ENTECAVIR","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/21\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"05\/31\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/31\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-05-31
)
)