Application Sponsors
ANDA 207018 | UNICHEM LABS LTD | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | 12.5MG;150MG | 0 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN |
002 | TABLET;ORAL | 12.5MG;300MG | 0 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-09-19 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2021-05-21 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2021-05-21 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2021-12-08 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2021-12-08 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 2 | Null | 15 |
SUPPL | 3 | Null | 7 |
SUPPL | 4 | Null | 7 |
SUPPL | 6 | Null | 7 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
UNICHEM
cder:Array
(
[0] => Array
(
[ApplNo] => 207018
[companyName] => UNICHEM
[docInserts] => ["",""]
[products] => [{"drugName":"IRBESARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; IRBESARTAN","strength":"12.5MG;150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IRBESARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; IRBESARTAN","strength":"12.5MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/19\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2017-09-19
)
)