Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021158
Company: LG CHEM LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FACTIVE GEMIFLOXACIN MESYLATE EQ 320MG BASE 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
04/04/2003 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021158lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21158ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21158_Factive.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/03/2019 SUPPL-26 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021158s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021158Orig1s026ltr.pdf
10/18/2018 SUPPL-25 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021158s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021158Orig1s025ltr.pdf
12/13/2018 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021158s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021158s024ltr.pdf
07/26/2016 SUPPL-23 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/2016/021158s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021158Orig1s023ltr.pdf
08/14/2013 SUPPL-22 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021158s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021158Orig1s022ltr.pdf
10/18/2011 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021158s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021158s021ltr.pdf
08/04/2011 SUPPL-19 Labeling-Package Insert, REMS-Modified, REMS-Assessment

Label is not available on this site.

02/25/2011 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021158s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021158s018ltr.pdf
04/27/2009 SUPPL-14 Labeling, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021158s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021158s014ltr.pdf
10/29/2008 SUPPL-13 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021158s013lbl.pdf
10/03/2008 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021158s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021158s012ltr.pdf
12/19/2007 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021158s011ltr.pdf
05/01/2007 SUPPL-7 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021158s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021158s007ltr.pdf
10/26/2006 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021158s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021158s005ltr.pdf
09/07/2004 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21158s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21158s003ltr.pdf
07/28/2004 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21158s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21158s002ltr.pdf
07/25/2003 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21158se1-001_factive_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21158se1-001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/03/2019 SUPPL-26 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021158s026lbl.pdf
05/03/2019 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021158s026lbl.pdf
12/13/2018 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021158s024lbl.pdf
10/18/2018 SUPPL-25 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021158s025lbl.pdf
10/18/2018 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021158s025lbl.pdf
07/26/2016 SUPPL-23 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/2016/021158s023lbl.pdf
08/14/2013 SUPPL-22 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021158s022lbl.pdf
08/14/2013 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021158s022lbl.pdf
10/18/2011 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021158s021lbl.pdf
02/25/2011 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021158s018lbl.pdf
04/27/2009 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021158s014lbl.pdf
04/27/2009 SUPPL-14 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021158s014lbl.pdf
10/29/2008 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021158s013lbl.pdf
10/03/2008 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021158s012lbl.pdf
05/01/2007 SUPPL-7 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021158s007lbl.pdf
10/26/2006 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021158s005lbl.pdf
09/07/2004 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21158s003lbl.pdf
07/28/2004 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21158s002lbl.pdf
07/25/2003 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21158se1-001_factive_lbl.pdf
04/04/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021158lbl.pdf

FACTIVE

TABLET;ORAL; EQ 320MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FACTIVE GEMIFLOXACIN MESYLATE EQ 320MG BASE TABLET;ORAL Prescription Yes AB 021158 LG CHEM LTD
GEMIFLOXACIN MESYLATE GEMIFLOXACIN MESYLATE EQ 320MG BASE TABLET;ORAL Prescription No AB 090466 ORCHID HLTHCARE

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