Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208675
Company: SAGENT PHARMS INC
Company: SAGENT PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 36GM BASE/VIAL;EQ 4.5GM 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 |
---|---|---|---|---|---|---|---|
02/16/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/01/2024 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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03/28/2024 | SUPPL-4 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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03/28/2024 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
PIPERACILLIN AND TAZOBACTAM
INJECTABLE;INJECTION; EQ 36GM BASE/VIAL;EQ 4.5GM 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 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203720 | FRESENIUS KABI |
PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090498 | ISTITUTO BIO ITA SPA |
PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 207848 | PROVEPHARM SAS |
PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 208675 | SAGENT PHARMS INC |
PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203557 | SANDOZ |
PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 217243 | SHANDONG |
PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 207146 | WOCKHARDT BIO AG |