Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021158
Company: LG CHEM LTD
Company: LG CHEM LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FACTIVE | GEMIFLOXACIN MESYLATE | EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 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-Package Insert, Labeling-Medication Guide |
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 | REMS-Assessment, Labeling-Package Insert, REMS-Modified |
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 | REMS-Proposal, Labeling |
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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021158s022lbl.pdf | |
| 08/14/2013 | SUPPL-22 | Labeling-Medication Guide | 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 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021158s014lbl.pdf | |
| 04/27/2009 | SUPPL-14 | Labeling | 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 |