Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019735
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLOXIN OFLOXACIN 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
FLOXIN OFLOXACIN 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
FLOXIN OFLOXACIN 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No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
12/28/1990 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/25/2011 SUPPL-61 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019735s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019735s061ltr.pdf
02/12/2009 SUPPL-60 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019735s060ltr.pdf
10/03/2008 SUPPL-59 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019735s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019735s059ltr.pdf
12/13/2007 SUPPL-58 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019735s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019735s058ltr..pdf
06/19/2007 SUPPL-57 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019735s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019735s057ltr.pdf
05/16/2007 SUPPL-56 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019735s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019735s056ltr.pdf
06/14/2006 SUPPL-55 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019735s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019735s055LTR.pdf
01/20/2006 SUPPL-54 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019735s054LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019735s054ltr.pdf
09/15/2004 SUPPL-53 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19735s052,053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19735s052,053ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019735_S053_floxin.pdf
09/15/2004 SUPPL-52 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19735s052,053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19735s052,053ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019735_S052_Floxin.pdf
03/06/2004 SUPPL-51 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19735slr051_floxin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19735slr051ltr.pdf
10/30/2000 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

12/08/1999 SUPPL-49 Labeling

Label is not available on this site.

09/08/1999 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

12/08/1999 SUPPL-47 Labeling

Label is not available on this site.

03/25/1999 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

12/08/1999 SUPPL-45 Labeling

Label is not available on this site.

09/21/1998 SUPPL-44 Labeling

Label is not available on this site.

06/28/1996 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

12/19/1996 SUPPL-42 Efficacy-New Indication

Label is not available on this site.

11/09/1995 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

09/22/1995 SUPPL-40 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/11/1997 SUPPL-39 Labeling

Label is not available on this site.

09/11/1996 SUPPL-38 Labeling

Label is not available on this site.

08/08/1994 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1995 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

12/07/1993 SUPPL-34 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/30/1993 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

11/30/1993 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

11/30/1993 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

07/21/1994 SUPPL-24 Labeling

Label is not available on this site.

09/03/1992 SUPPL-23 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019735_S023_FLOXIN.pdf
09/03/1992 SUPPL-22 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019735_S022_FLOXIN.pdf
08/11/1993 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

09/10/1992 SUPPL-19 Manufacturing (CMC)-Formulation Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019735_S019_Floxin.pdf
12/08/1992 SUPPL-18 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019735_S018_Floxin.pdf
07/14/1992 SUPPL-16 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019735_s016_FloxinTOC.cfm
09/20/1993 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

06/23/1992 SUPPL-8 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019735_s008_FloxinTOC.cfm
05/15/1992 SUPPL-7 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019735_s007_FloxinTOC.cfm
12/13/1991 SUPPL-4 Manufacturing (CMC) Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019735_s004_FloxinTOC.cfm
02/28/1991 SUPPL-1 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019735_s001_FloxinTOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/25/2011 SUPPL-61 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019735s061lbl.pdf
10/03/2008 SUPPL-59 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019735s059lbl.pdf
12/13/2007 SUPPL-58 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019735s058lbl.pdf
06/19/2007 SUPPL-57 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019735s057lbl.pdf
05/16/2007 SUPPL-56 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019735s056lbl.pdf
06/14/2006 SUPPL-55 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019735s055lbl.pdf
01/20/2006 SUPPL-54 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019735s054LBL.pdf
09/15/2004 SUPPL-53 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19735s052,053lbl.pdf
09/15/2004 SUPPL-52 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19735s052,053lbl.pdf
03/06/2004 SUPPL-51 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19735slr051_floxin_lbl.pdf

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