Application Sponsors
| ANDA 077820 | SUN PHARM INDS INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 5MG | 0 | GLIPIZIDE | GLIPIZIDE |
| 002 | TABLET;ORAL | 10MG | 0 | GLIPIZIDE | GLIPIZIDE |
FDA Submissions
| ORIG | 1 | AP | 2006-07-11 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2009-03-23 | |
| LABELING; Labeling | SUPPL | 8 | AP | 2015-08-17 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2015-08-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2015-06-17 | UNKNOWN |
| LABELING; Labeling | SUPPL | 12 | AP | 2017-03-31 | STANDARD |
Submissions Property Types
| SUPPL | 8 | Null | 7 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 12 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
SUN PHARM INDS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 77820
[companyName] => SUN PHARM INDS INC
[docInserts] => ["",""]
[products] => [{"drugName":"GLIPIZIDE","activeIngredients":"GLIPIZIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GLIPIZIDE","activeIngredients":"GLIPIZIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"GLIPIZIDE","submission":"GLIPIZIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GLIPIZIDE","submission":"GLIPIZIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)