Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065386
Company: HOSPIRA INC
Company: HOSPIRA INC
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 | Discontinued | None | No | No |
PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
09/15/2009 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/065386lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/065386s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/23/2017 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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10/23/2017 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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10/23/2017 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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10/23/2017 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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10/23/2017 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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10/23/2017 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/15/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/065386lbl.pdf |