Application Sponsors
ANDA 203277 | HETERO LABS LTD V | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | 150MG | 0 | LAMIVUDINE | LAMIVUDINE |
002 | TABLET;ORAL | 300MG | 0 | LAMIVUDINE | LAMIVUDINE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2014-01-06 | |
LABELING; Labeling | SUPPL | 2 | AP | 2019-09-26 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2019-09-26 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2019-09-26 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2019-09-26 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 19 |
SUPPL | 2 | Null | 7 |
SUPPL | 3 | Null | 7 |
SUPPL | 4 | Null | 15 |
SUPPL | 5 | Null | 15 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
HETERO LABS LTD V
cder:Array
(
[0] => Array
(
[ApplNo] => 203277
[companyName] => HETERO LABS LTD V
[docInserts] => ["",""]
[products] => [{"drugName":"LAMIVUDINE","activeIngredients":"LAMIVUDINE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMIVUDINE","activeIngredients":"LAMIVUDINE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/06\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"09\/26\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/26\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/26\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/26\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/26\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-09-26
)
)