Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | 0 | PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
002 | INJECTABLE;INJECTION | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | 0 | PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
003 | INJECTABLE;INJECTION | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | 0 | PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-08-10 | |
LABELING; Labeling | SUPPL | 4 | AP | 2021-07-22 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2022-02-15 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 15 |
SUPPL | 4 | Null | 7 |
SUPPL | 6 | Null | 7 |
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
003 | Prescription | AP |
CDER Filings
QILU
cder:Array
(
[0] => Array
(
[ApplNo] => 204959
[companyName] => QILU
[docInserts] => ["",""]
[products] => [{"drugName":"PIPERACILLIN AND TAZOBACTAM","activeIngredients":"PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","strength":"EQ 2GM BASE\/VIAL;EQ 250MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PIPERACILLIN AND TAZOBACTAM","activeIngredients":"PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","strength":"EQ 3GM BASE\/VIAL;EQ 375MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PIPERACILLIN AND TAZOBACTAM","activeIngredients":"PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","strength":"EQ 4GM BASE\/VIAL;EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/10\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-08-10
)
)