Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL | 0 | PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
| 002 | INJECTABLE;INJECTION | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL | 0 | PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2014-10-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2016-03-24 | UNKNOWN |
| LABELING; Labeling | SUPPL | 11 | AP | 2019-08-30 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2019-08-30 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2021-07-08 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2021-12-08 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 1 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 22 | Null | 15 |
| SUPPL | 24 | Null | 15 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
SANDOZ INC
cder:Array
(
[0] => Array
(
[ApplNo] => 203557
[companyName] => SANDOZ INC
[docInserts] => ["",""]
[products] => [{"drugName":"PIPERACILLIN AND TAZOBACTAM","activeIngredients":"PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","strength":"EQ 12GM BASE\/VIAL;EQ 1.5GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/29\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"08\/30\/2019","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/30\/2019","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/24\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-08-30
)
)