Application Sponsors
| ANDA 204720 | UNIQUE PHARM LABS | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 2.5MG | 0 | GLIPIZIDE | GLIPIZIDE |
| 002 | TABLET, EXTENDED RELEASE;ORAL | 5MG | 0 | GLIPIZIDE | GLIPIZIDE |
| 003 | TABLET, EXTENDED RELEASE;ORAL | 10MG | 0 | GLIPIZIDE | GLIPIZIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2016-12-29 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2019-04-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2022-07-01 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 11 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
UNIQUE PHARM LABS
cder:Array
(
[0] => Array
(
[ApplNo] => 204720
[companyName] => UNIQUE PHARM LABS
[docInserts] => ["",""]
[products] => [{"drugName":"GLIPIZIDE","activeIngredients":"GLIPIZIDE","strength":"2.5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GLIPIZIDE","activeIngredients":"GLIPIZIDE","strength":"5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GLIPIZIDE","activeIngredients":"GLIPIZIDE","strength":"10MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/29\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"04\/23\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-04-23
)
)