Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019735
Company: JANSSEN PHARMS
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| FLOXIN | OFLOXACIN | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| FLOXIN | OFLOXACIN | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| FLOXIN | OFLOXACIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 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 |