Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021130
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZYVOX LINEZOLID 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
ZYVOX LINEZOLID 600MG TABLET;ORAL Prescription AB 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 1 - New Molecular Entity 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
02/01/2018 SUPPL-37 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-35 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-34 Labeling-Package Insert, Labeling-Container/Carton Labels 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-33 Manufacturing (CMC)

Label is not available on this site.

01/24/2014 SUPPL-32 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-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021130s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021130s028,021131s024,021132s027ltr.pdf
05/03/2013 SUPPL-24 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-23 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-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021130s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021131s020,s021132s021,021130s022ltr.pdf
12/08/2009 SUPPL-20 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
02/19/2008 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

09/18/2007 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

06/20/2008 SUPPL-17 Labeling-Package Insert 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-16 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
06/08/2007 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/21/2007 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/2007 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

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/2007/021130Orig1s012.pdf
11/02/2005 SUPPL-10 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-9 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-8 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-7 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-6 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-5 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
02/01/2018 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021130s037,021131s030,021132s035lbl.pdf
07/13/2017 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021130Origs034,021131Orig1s028,021132Orig1s033lbl.pdf
07/13/2017 SUPPL-34 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021130Origs034,021131Orig1s028,021132Orig1s033lbl.pdf
06/05/2015 SUPPL-35 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-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021130s032,021131s026,021132s031lbl.pdf
05/03/2013 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021130s023s024,021131s021s022,021132s022s023lbl.pdf
05/03/2013 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021130s023s024,021131s021s022,021132s022s023lbl.pdf
02/13/2012 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021130s028lbl.pdf
07/16/2010 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021130s022lbl.pdf
12/08/2009 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021130s020,021131s017,021132s018lbl.pdf
06/20/2008 SUPPL-16 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-9 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-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021130s008,009,021131s009,010,021132s008,009lbl.pdf
06/23/2004 SUPPL-6 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

TABLET;ORAL; 600MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LINEZOLID LINEZOLID 600MG TABLET;ORAL Prescription No AB 205233 ALEMBIC PHARMS LTD
LINEZOLID LINEZOLID 600MG TABLET;ORAL Prescription No AB 205517 ALKEM LABS LTD
LINEZOLID LINEZOLID 600MG TABLET;ORAL Prescription No AB 204536 AMNEAL PHARMS
LINEZOLID LINEZOLID 600MG TABLET;ORAL Prescription No AB 210702 CELLTRION
LINEZOLID LINEZOLID 600MG TABLET;ORAL Prescription No AB 091210 GATE PHARMS
LINEZOLID LINEZOLID 600MG TABLET;ORAL Prescription No AB 078987 GLENMARK PHARMS
LINEZOLID LINEZOLID 600MG TABLET;ORAL Prescription No AB 204239 HETERO LABS LTD V
LINEZOLID LINEZOLID 600MG TABLET;ORAL Prescription No AB 078845 MYLAN
LINEZOLID LINEZOLID 600MG TABLET;ORAL Prescription No AB 207526 NOVEL LABS INC
LINEZOLID LINEZOLID 600MG TABLET;ORAL Prescription No AB 078061 TEVA PHARMS USA
LINEZOLID LINEZOLID 600MG TABLET;ORAL Prescription No AB 206097 ZYDUS PHARMS
ZYVOX LINEZOLID 600MG TABLET;ORAL Prescription Yes AB 021130 PHARMACIA AND UPJOHN

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