Application Sponsors
| ANDA 074223 | WATSON LABS TEVA | |
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 | 1995-02-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1999-11-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1999-11-05 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2000-01-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2001-09-05 | |
| LABELING; Labeling | SUPPL | 6 | AP | 2001-09-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2002-06-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2002-06-13 | |
| LABELING; Labeling | SUPPL | 16 | AP | 2013-07-26 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2016-01-05 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2021-05-16 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 16 | Null | 15 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 19 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
WATSON LABS TEVA
cder:Array
(
[0] => Array
(
[ApplNo] => 74223
[companyName] => WATSON LABS TEVA
[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
)
)