Application Sponsors
| ANDA 091401 | SUN PHARM INDS INC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | CAPSULE;ORAL | 25MG | 0 | INDOMETHACIN | INDOMETHACIN |
| 002 | CAPSULE;ORAL | 50MG | 0 | INDOMETHACIN | INDOMETHACIN |
FDA Submissions
| ORIG | 1 | AP | 2013-03-28 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2016-05-09 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2021-04-29 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2021-04-29 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 7 |
CDER Filings
SUN PHARM INDS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 91401
[companyName] => SUN PHARM INDS INC
[docInserts] => ["",""]
[products] => [{"drugName":"INDOMETHACIN","activeIngredients":"INDOMETHACIN","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"INDOMETHACIN","activeIngredients":"INDOMETHACIN","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"INDOMETHACIN","submission":"INDOMETHACIN","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"INDOMETHACIN","submission":"INDOMETHACIN","actionType":"50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)