Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021131
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZYVOX | LINEZOLID | 200MG/100ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | Yes | No |
| ZYVOX | LINEZOLID | 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAVENOUS | Discontinued | None | Yes | No |
| ZYVOX | LINEZOLID | 600MG/300ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/18/2000 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21130lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21130ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21130_Zyvox.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/18/2023 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021130s044,021131s041,021132s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021130Orig1s044;021131Orig1s041;021132Orig1s043ltr.pdf | |
| 11/10/2021 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021131s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021131Orig1s040ltr.pdf | |
| 10/26/2021 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021130s043,021131s039,021132s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021130Orig1s043; 021131Orig1s039; 021132Orig1s042ltr.pdf | |
| 09/01/2021 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021130s042,021131s038,021132s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021130Orig1s042; 021131Orig1s038; 021132Orig1s041ltr.pdf | |
| 07/16/2021 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021130s041,021131s037,021132s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021130Orig1s041; 021131Orig1s037; 021132Orig1s040ltr.pdf | |
| 08/05/2020 | SUPPL-35 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021130s039s040,021131s034s035,021132s038s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021130Orig1s039, s040; 021131Orig1s034, s035; 021132Orig1s038, s039ltr.pdf | |
| 08/05/2020 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021130s039s040,021131s034s035,021132s038s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021130Orig1s039, s040; 021131Orig1s034, s035; 021132Orig1s038, s039ltr.pdf | |
| 02/01/2018 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021130s037,021131s030,021132s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021130Orig1s037,021131Orig1s030,021132Orig1s035ltr.pdf | |
| 06/05/2015 | SUPPL-29 | 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/2015/021130s030,021131s029,021132s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021130Orig1s035,021131Orig1s029,021132Orig1s034ltr.pdf |
| 07/13/2017 | SUPPL-28 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021130Origs034,021131Orig1s028,021132Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021130Origs034,021131Orig1s028,021132Orig1s033ltr.pdf | |
| 07/28/2014 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/2014 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021130s032,021131s026,021132s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021130Orig1s032,021131Orig1s026,021132Orig1s031ltr.pdf | |
| 02/13/2012 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021131s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021130s028,021131s024,021132s027ltr.pdf | |
| 05/03/2013 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021130s023s024,021131s021s022,021132s022s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021130Orig1s023,s024,021131Origs021,s022,021132Orig1s022,s023ltr.pdf | |
| 05/03/2013 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021130s023s024,021131s021s022,021132s022s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021130Orig1s023,s024,021131Origs021,s022,021132Orig1s022,s023ltr.pdf | |
| 07/16/2010 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021131s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021131s020,s021132s021,021130s022ltr.pdf | |
| 12/08/2009 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021130s020,021131s017,021132s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021130s020,021131s017,021132s018ltr.pdf | |
| 09/18/2007 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/02/2007 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/20/2008 | SUPPL-14 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021130s016,s017,021131s013,s014,021132s014,s015ltr.pdf |
| 06/20/2008 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021130s016,021131s013,021132s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021130s016,s017,021131s013,s014,021132s014,s015ltr.pdf | |
| 04/26/2007 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021130s012,021131s012,021132s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021130s012,021131s012,021132s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021131Orig1s012.pdf | |
| 11/02/2005 | SUPPL-11 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021130s010,021131s011,021132s010ltr.pdf |
| 05/12/2005 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021130s008,009,021131s009,010,021132s008,009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021130s008,009,021131s009,010,021132s008,009ltr.pdf | |
| 05/12/2005 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021130s008,009,021131s009,010,021132s008,009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021130s008,009,021131s009,010,021132s008,009ltr.pdf | |
| 02/10/2005 | SUPPL-8 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21130s007,21131s008,21132s007ltr.pdf |
| 06/23/2004 | SUPPL-7 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21130se5-006,21131se5-007,21132se5-006_zyvox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21130se5-006,21131se5-007,21132se5-006ltr.pdf | |
| 01/05/2004 | SUPPL-6 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21130slr005,21131slr006,21132slr005ltr.pdf |
| 07/22/2003 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21130se8-004,21131se8-004,21132se8-004ltr.pdf |
| 12/19/2002 | SUPPL-3 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21132se5-003,21131se5-003,21130se5-003_zyvox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21132se5-003,21131se5-003,21130se5-003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-130s003_21131s003_21132s003_ZyvoxTOC.cfm | |
| 12/19/2002 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21130slr002,21131slr002,21132slr002_zyvox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21130slr002,21131slr002,21132slr002ltr.pdf | |
| 02/06/2001 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/18/2023 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021130s044,021131s041,021132s043lbl.pdf | |
| 11/10/2021 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021131s040lbl.pdf | |
| 10/26/2021 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021130s043,021131s039,021132s042lbl.pdf | |
| 09/01/2021 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021130s042,021131s038,021132s041lbl.pdf | |
| 07/16/2021 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021130s041,021131s037,021132s040lbl.pdf | |
| 08/05/2020 | SUPPL-35 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021130s039s040,021131s034s035,021132s038s039lbl.pdf | |
| 08/05/2020 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021130s039s040,021131s034s035,021132s038s039lbl.pdf | |
| 08/05/2020 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021130s039s040,021131s034s035,021132s038s039lbl.pdf | |
| 02/01/2018 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021130s037,021131s030,021132s035lbl.pdf | |
| 07/13/2017 | SUPPL-28 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021130Origs034,021131Orig1s028,021132Orig1s033lbl.pdf | |
| 07/13/2017 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021130Origs034,021131Orig1s028,021132Orig1s033lbl.pdf | |
| 06/05/2015 | SUPPL-29 | 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/2015/021130s030,021131s029,021132s034lbl.pdf |
| 01/24/2014 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021130s032,021131s026,021132s031lbl.pdf | |
| 05/03/2013 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021130s023s024,021131s021s022,021132s022s023lbl.pdf | |
| 05/03/2013 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021130s023s024,021131s021s022,021132s022s023lbl.pdf | |
| 02/13/2012 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021131s024lbl.pdf | |
| 07/16/2010 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021131s020lbl.pdf | |
| 12/08/2009 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021130s020,021131s017,021132s018lbl.pdf | |
| 06/20/2008 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021130s016,021131s013,021132s014lbl.pdf | |
| 04/26/2007 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021130s012,021131s012,021132s012lbl.pdf | |
| 05/12/2005 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021130s008,009,021131s009,010,021132s008,009lbl.pdf | |
| 05/12/2005 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021130s008,009,021131s009,010,021132s008,009lbl.pdf | |
| 06/23/2004 | SUPPL-7 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21130se5-006,21131se5-007,21132se5-006_zyvox_lbl.pdf | |
| 12/19/2002 | SUPPL-3 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21132se5-003,21131se5-003,21130se5-003_zyvox_lbl.pdf | |
| 12/19/2002 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21130slr002,21131slr002,21132slr002_zyvox_lbl.pdf | |
| 04/18/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21130lbl.pdf |
ZYVOX
SOLUTION;INTRAVENOUS; 200MG/100ML (2MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LINEZOLID | LINEZOLID | 200MG/100ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 207001 | HQ SPCLT PHARMA |
| LINEZOLID | LINEZOLID | 200MG/100ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 205154 | MYLAN LABS LTD |
| LINEZOLID | LINEZOLID | 200MG/100ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 207354 | NANG KUANG PHARM CO |
| LINEZOLID | LINEZOLID | 200MG/100ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 204696 | SAGENT PHARMS INC |
| LINEZOLID | LINEZOLID | 200MG/100ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 200904 | SANDOZ |
| ZYVOX | LINEZOLID | 200MG/100ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 021131 | PFIZER |
SOLUTION;INTRAVENOUS; 600MG/300ML (2MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LINEZOLID | LINEZOLID | 600MG/300ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 206917 | EUGIA PHARMA |
| LINEZOLID | LINEZOLID | 600MG/300ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 204764 | FRESENIUS KABI USA |
| LINEZOLID | LINEZOLID | 600MG/300ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 206454 | HIKMA |
| LINEZOLID | LINEZOLID | 600MG/300ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 207001 | HQ SPCLT PHARMA |
| LINEZOLID | LINEZOLID | 600MG/300ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 205154 | MYLAN LABS LTD |
| LINEZOLID | LINEZOLID | 600MG/300ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 207354 | NANG KUANG PHARM CO |
| LINEZOLID | LINEZOLID | 600MG/300ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 204696 | SAGENT PHARMS INC |
| LINEZOLID | LINEZOLID | 600MG/300ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 200904 | SANDOZ |
| ZYVOX | LINEZOLID | 600MG/300ML (2MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 021131 | PFIZER |