Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207848
Company: PROVEPHARM SAS
Company: PROVEPHARM SAS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
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 |
---|---|---|---|---|---|---|---|
05/11/2018 | ORIG-2 | Approval | STANDARD |
Label is not available on this site. |
|||
01/13/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
PIPERACILLIN AND TAZOBACTAM
INJECTABLE;INJECTION; EQ 12GM BASE/VIAL;EQ 1.5GM 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 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 206204 | FRESENIUS KABI USA |
PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 207848 | PROVEPHARM SAS |
PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203557 | SANDOZ INC |
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 | 207146 | WOCKHARDT BIO AG |
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