Application Sponsors
ANDA 209261 | UNICHEM LABS LTD | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Application Products
001 | TABLET;ORAL | 40MG | 0 | VALSARTAN | VALSARTAN |
002 | TABLET;ORAL | 80MG | 0 | VALSARTAN | VALSARTAN |
003 | TABLET;ORAL | 160MG | 0 | VALSARTAN | VALSARTAN |
004 | TABLET;ORAL | 320MG | 0 | VALSARTAN | VALSARTAN |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-05-04 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2019-08-20 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
CDER Filings
UNICHEM LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 209261
[companyName] => UNICHEM LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"VALSARTAN","activeIngredients":"VALSARTAN","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VALSARTAN","activeIngredients":"VALSARTAN","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VALSARTAN","activeIngredients":"VALSARTAN","strength":"160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VALSARTAN","activeIngredients":"VALSARTAN","strength":"320MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/04\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"08\/20\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-08-20
)
)