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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 014214
Company: SANOFI AVENTIS US

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEGGRAM NALIDIXIC ACID 250MG TABLET;ORAL Discontinued None No No
NEGGRAM NALIDIXIC ACID 500MG TABLET;ORAL Discontinued None No No
NEGGRAM NALIDIXIC ACID 1GM 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
03/06/1964 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/28/2012 SUPPL-60 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014214s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/014214Orig1s060ltr.pdf
04/29/2011 SUPPL-59 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014214s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/014214s059ltr.pdf
03/28/2009 SUPPL-58 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/014214s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/014214s058ltr.pdf
05/24/2007 SUPPL-57 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/014214s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/014214s057ltr.pdf
09/07/2004 SUPPL-56 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/14214s053,055,056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/14214s053,055,056ltr.pdf
09/07/2004 SUPPL-55 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/14214s053,055,056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/14214s053,055,056ltr.pdf
09/07/2004 SUPPL-53 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/14214s053,055,056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/14214s053,055,056ltr.pdf
09/20/2002 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.
11/23/1999 SUPPL-51 Labeling Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/17-430s026s027_14-214s050s051_Negram.cfm
11/23/1999 SUPPL-50 Labeling Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/17-430s026s027_14-214s050s051_Negram.cfm
10/03/1995 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.
06/24/1991 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.
09/17/1990 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.
10/05/1990 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.
07/20/1990 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.
02/07/1995 SUPPL-44 Labeling

Label is not available on this site.
03/21/1986 SUPPL-43 Manufacturing (CMC)-Packaging

Label is not available on this site.
04/28/1986 SUPPL-42 Labeling

Label is not available on this site.
08/17/1983 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.
08/18/1981 SUPPL-38 Manufacturing (CMC)-Packaging

Label is not available on this site.
06/04/1981 SUPPL-37 Manufacturing (CMC)-Packaging

Label is not available on this site.
06/04/1981 SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.
08/18/1981 SUPPL-35 Manufacturing (CMC)-Packaging

Label is not available on this site.
12/12/1980 SUPPL-34 Labeling

Label is not available on this site.
04/09/1980 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.
02/13/1979 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.
07/11/1978 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.
02/23/1981 SUPPL-30 Labeling

Label is not available on this site.
05/03/1978 SUPPL-29 Labeling

Label is not available on this site.
06/29/1977 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.
03/31/1976 SUPPL-24 Labeling

Label is not available on this site.
04/08/1976 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.
09/08/1975 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.
07/18/1975 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.
02/23/1977 SUPPL-20

Label is not available on this site.
02/26/1975 SUPPL-14

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/28/2012 SUPPL-60 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014214s060lbl.pdf
04/29/2011 SUPPL-59 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014214s059lbl.pdf
03/28/2009 SUPPL-58 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/014214s058lbl.pdf
05/24/2007 SUPPL-57 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/014214s057lbl.pdf
09/07/2004 SUPPL-56 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/14214s053,055,056lbl.pdf
09/07/2004 SUPPL-55 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/14214s053,055,056lbl.pdf
09/07/2004 SUPPL-53 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/14214s053,055,056lbl.pdf
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