Application Sponsors
| ANDA 090032 | GLENMARK PHARMS LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 20MG | 0 | TELMISARTAN | TELMISARTAN |
| 002 | TABLET;ORAL | 40MG | 0 | TELMISARTAN | TELMISARTAN |
| 003 | TABLET;ORAL | 80MG | 0 | TELMISARTAN | TELMISARTAN |
FDA Submissions
| ORIG | 1 | AP | 2014-07-07 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2015-11-17 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2021-03-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2021-10-15 | |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
GLENMARK PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 90032
[companyName] => GLENMARK PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"TELMISARTAN","activeIngredients":"TELMISARTAN","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TELMISARTAN","activeIngredients":"TELMISARTAN","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TELMISARTAN","activeIngredients":"TELMISARTAN","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TELMISARTAN","submission":"TELMISARTAN","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TELMISARTAN","submission":"TELMISARTAN","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TELMISARTAN","submission":"TELMISARTAN","actionType":"80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)