Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065458
Company: ONESOURCE SPECIALTY
Company: ONESOURCE SPECIALTY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/15/2014 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/03/2024 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/01/2024 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/09/2024 | SUPPL-15 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 12/09/2022 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/18/2021 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/30/2019 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/30/2019 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
PIPERACILLIN AND TAZOBACTAM
INJECTABLE;INJECTION; EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 206996 | APOTEX |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065498 | EUGIA PHARMA SPECLTS |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203719 | FRESENIUS KABI |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065523 | ISTITUTO BIO ITA SPA |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 207847 | MILLA PHARMS |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065458 | ONESOURCE SPECIALTY |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 208674 | SAGENT PHARMS INC |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065362 | SANDOZ |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065363 | SANDOZ |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204959 | SHANDONG |
INJECTABLE;INJECTION; EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 206996 | APOTEX |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065498 | EUGIA PHARMA SPECLTS |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203719 | FRESENIUS KABI |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065523 | ISTITUTO BIO ITA SPA |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 207847 | MILLA PHARMS |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065458 | ONESOURCE SPECIALTY |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 208674 | SAGENT PHARMS INC |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065362 | SANDOZ |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065363 | SANDOZ |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204959 | SHANDONG |
INJECTABLE;INJECTION; EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 206996 | APOTEX |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065498 | EUGIA PHARMA SPECLTS |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203719 | FRESENIUS KABI |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065523 | ISTITUTO BIO ITA SPA |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 207847 | MILLA PHARMS |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065458 | ONESOURCE SPECIALTY |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 208674 | SAGENT PHARMS INC |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065362 | SANDOZ |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065363 | SANDOZ |
| PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204959 | SHANDONG |