Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050679
Company: HOSPIRA INC
Company: HOSPIRA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MAXIPIME | CEFEPIME HYDROCHLORIDE | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| MAXIPIME | CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| MAXIPIME | CEFEPIME HYDROCHLORIDE | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 01/18/1996 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050679Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/11/2021 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050679s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050679Orig1s046ltr.pdf | |
| 05/03/2017 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050679s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050679Orig1s042ltr.pdf |
| 06/22/2016 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/2016 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050679s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050679Orig1s040ltr.pdf | |
| 03/04/2016 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/2014 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/06/2012 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050679s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050679Orig1s036ltr.pdf | |
| 03/15/2013 | SUPPL-34 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050679s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050679Orig1s034ltr.pdf | |
| 09/30/2009 | SUPPL-32 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050679s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050679s032ltr.pdf | |
| 05/01/2014 | SUPPL-31 | Labeling, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050679s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050679Orig1s031ltr.pdf | |
| 09/14/2007 | SUPPL-28 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050679s028lbl.pdf | |
| 09/14/2007 | SUPPL-24 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050679s024ltr_CKD.pdf |
| 06/09/2004 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50679slr023_maxipime_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50679slr023ltr.pdf | |
| 03/17/2003 | SUPPL-21 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50679se2-021_maxipime_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50679se2-021ltr.pdf | |
| 03/15/2002 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/20/2001 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/21/2002 | SUPPL-18 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50679slr009,014,018ltr.pdf |
| 04/02/2001 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/10/2000 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/2000 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 08/21/2002 | SUPPL-14 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50679slr009,014,018ltr.pdf |
| 09/20/2000 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 11/24/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/21/1998 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/30/1998 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/21/2002 | SUPPL-9 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50679slr009,014,018ltr.pdf |
| 01/30/1998 | SUPPL-8 | Efficacy-New Indication |
Label is not available on this site. |
||
| 01/27/1999 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50679S007_Maxipine_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50679S007_Maxipine_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50679S007_Maxipine.cfm | |
| 02/08/1999 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 10/20/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1996 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/1997 | SUPPL-2 | Efficacy-New Indication |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050679s002.cfm |
| 03/13/1996 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/11/2021 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050679s046lbl.pdf | |
| 05/03/2017 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050679s042lbl.pdf |
| 03/01/2016 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050679s040lbl.pdf | |
| 05/01/2014 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050679s031lbl.pdf | |
| 05/01/2014 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050679s031lbl.pdf | |
| 03/15/2013 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050679s034lbl.pdf | |
| 09/06/2012 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050679s036lbl.pdf | |
| 09/30/2009 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050679s032lbl.pdf | |
| 09/14/2007 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050679s028lbl.pdf | |
| 06/09/2004 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50679slr023_maxipime_lbl.pdf | |
| 03/17/2003 | SUPPL-21 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50679se2-021_maxipime_lbl.pdf | |
| 01/27/1999 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50679S007_Maxipine_prntlbl.pdf |