Application Sponsors
| ANDA 091240 | HETERO LABS LTD III | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE;ORAL | 25MG | 0 | INDOMETHACIN | INDOMETHACIN |
| 002 | CAPSULE;ORAL | 50MG | 0 | INDOMETHACIN | INDOMETHACIN |
FDA Submissions
| ORIG | 1 | AP | 2011-04-12 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2021-04-26 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2021-04-28 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 9 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
HETERO LABS LTD III
cder:Array
(
[0] => Array
(
[ApplNo] => 91240
[companyName] => HETERO LABS LTD III
[docInserts] => ["",""]
[products] => [{"drugName":"INDOMETHACIN","activeIngredients":"INDOMETHACIN","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"INDOMETHACIN","activeIngredients":"INDOMETHACIN","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"INDOMETHACIN","submission":"INDOMETHACIN","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"INDOMETHACIN","submission":"INDOMETHACIN","actionType":"50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)