Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019384
Company: MERCK
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NOROXIN | NORFLOXACIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/31/1986 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019384Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/26/2016 | SUPPL-67 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019384s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019384Orig1s067ltr.pdf | |
| 08/14/2013 | SUPPL-66 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019384s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019384Orig1s066ltr.pdf | |
| 03/27/2013 | SUPPL-65 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019384s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019384Orig1s065ltr.pdf | |
| 06/15/2012 | SUPPL-63 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019384s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019384s063ltr.pdf | |
| 02/09/2012 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019384s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019384s062ltr.pdf | |
| 09/16/2011 | SUPPL-61 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019384s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019384s061ltr.pdf | |
| 10/18/2011 | SUPPL-60 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019384s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019384s060ltr.pdf | |
| 05/27/2011 | SUPPL-59 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019384s059ltr.pdf |
| 09/08/2011 | SUPPL-58 | REMS |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019384s058ltr.pdf |
| 02/25/2011 | SUPPL-56 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019384s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019384s056ltr.pdf | |
| 06/10/2011 | SUPPL-55 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf |
| 04/27/2009 | SUPPL-54 | REMS-Proposal, Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019384s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019384s054ltr.pdf | |
| 02/12/2009 | SUPPL-53 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019384s053ltr.pdf |
| 10/03/2008 | SUPPL-52 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019384s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019384s052ltr.pdf | |
| 09/23/2008 | SUPPL-50 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019384s049s050lbl.pdf | |
| 09/23/2008 | SUPPL-49 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019384s049ltr.pdf |
| 03/14/2007 | SUPPL-48 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019384s048lbl.pdf |
| 03/20/2007 | SUPPL-47 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/22/2006 | SUPPL-46 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019384s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019384s046LTR.pdf | |
| 05/16/2006 | SUPPL-45 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019384s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019384s045LTR.pdf | |
| 07/23/2004 | SUPPL-43 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19384s040,042,043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19384s040,042,043ltr.pdf | |
| 07/23/2004 | SUPPL-42 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19384s040,042,043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19384s040,042,043ltr.pdf | |
| 07/23/2004 | SUPPL-40 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19384s040,042,043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19384s040,042,043ltr.pdf | |
| 04/16/2001 | SUPPL-39 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19384S38ltr.pdf |
| 04/16/2001 | SUPPL-38 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19384S38ltr.pdf |
| 04/16/2001 | SUPPL-37 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19384S38ltr.pdf |
| 06/20/1997 | SUPPL-36 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019384_S036_NOROXIN.pdf |
| 12/06/1996 | SUPPL-35 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019384_S035_NOROXIN.pdf |
| 07/18/1996 | SUPPL-34 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019384_S034_NOROXIN.pdf |
| 06/18/1996 | SUPPL-32 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019384_S032_NOROXIN.pdf |
| 01/15/1997 | SUPPL-31 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019384_S031_NOROXIN.pdf |
| 07/18/1996 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019384_S030_NOROXIN.pdf |
| 09/12/1996 | SUPPL-29 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019384_S029_NOROXIN.pdf |
| 12/26/1995 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1995 | SUPPL-27 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019384_S027_NOROXIN.pdf |
| 02/09/1998 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 07/01/1994 | SUPPL-24 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019384_S024_NOROXIN.pdf |
| 06/29/1993 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 10/24/1994 | SUPPL-20 | Efficacy-New Indication |
Label is not available on this site. |
||
| 05/06/1992 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/06/1992 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 04/17/1992 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 11/26/1991 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 11/26/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 11/26/1991 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 11/26/1991 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 11/26/1991 | SUPPL-11 | Efficacy-New Indication |
Label is not available on this site. |
||
| 11/26/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 06/28/1988 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/26/1991 | SUPPL-7 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 01/28/1988 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 01/28/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/28/1988 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 03/18/1987 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/26/2016 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019384s067lbl.pdf | |
| 08/14/2013 | SUPPL-66 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019384s066lbl.pdf | |
| 03/27/2013 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019384s065lbl.pdf | |
| 06/15/2012 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019384s063lbl.pdf | |
| 02/09/2012 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019384s062lbl.pdf | |
| 10/18/2011 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019384s060lbl.pdf | |
| 09/16/2011 | SUPPL-61 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019384s061lbl.pdf | |
| 02/25/2011 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019384s056lbl.pdf | |
| 04/27/2009 | SUPPL-54 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019384s054lbl.pdf | |
| 04/27/2009 | SUPPL-54 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019384s054lbl.pdf | |
| 10/03/2008 | SUPPL-52 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019384s052lbl.pdf | |
| 09/23/2008 | SUPPL-50 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019384s049s050lbl.pdf | |
| 09/22/2006 | SUPPL-46 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019384s046lbl.pdf | |
| 05/16/2006 | SUPPL-45 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019384s045lbl.pdf | |
| 07/23/2004 | SUPPL-43 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19384s040,042,043lbl.pdf | |
| 07/23/2004 | SUPPL-42 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19384s040,042,043lbl.pdf | |
| 07/23/2004 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19384s040,042,043lbl.pdf |