Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 019384
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NOROXIN NORFLOXACIN 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English