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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017430
Company: SANOFI AVENTIS US

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEGGRAM NALIDIXIC ACID 250MG/5ML SUSPENSION;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
04/17/1973 ORIG-1 Approval Type 3 - New Dosage Form 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
08/03/2007 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017430s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017430s032ltr.pdf
12/07/2007 SUPPL-31 Labeling

Label is not available on this site.
09/07/2004 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17430s028,029,030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17430s028,029,030ltr.pdf
09/07/2004 SUPPL-29 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17430s028,029,030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17430s028,029,030ltr.pdf
09/07/2004 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17430s028,029,030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17430s028,029,030ltr.pdf
11/23/1999 SUPPL-27 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-26 Labeling Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/17-430s026s027_14-214s050s051_Negram.cfm
10/31/1994 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.
08/03/1993 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.
06/24/1991 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.
05/13/1991 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.
07/30/1990 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.
07/13/1990 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
02/07/1995 SUPPL-19 Labeling

Label is not available on this site.
03/14/1988 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.
04/21/1986 SUPPL-17 Labeling

Label is not available on this site.
08/21/1987 SUPPL-16 Labeling

Label is not available on this site.
02/06/1984 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.
12/07/2007 SUPPL-14 Labeling

Label is not available on this site.
06/02/1983 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.
08/18/1981 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.
06/30/1980 SUPPL-11 Labeling

Label is not available on this site.
02/23/1981 SUPPL-10 Labeling

Label is not available on this site.
07/01/1977 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.
12/07/2007 SUPPL-8 Labeling

Label is not available on this site.
02/23/1977 SUPPL-7 Labeling

Label is not available on this site.
09/23/1976 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.
12/07/2007 SUPPL-5 Labeling

Label is not available on this site.
04/08/1976 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
02/28/1975 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.
03/13/1975 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
08/03/2007 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017430s032lbl.pdf
09/07/2004 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17430s028,029,030lbl.pdf
09/07/2004 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17430s028,029,030lbl.pdf
09/07/2004 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17430s028,029,030lbl.pdf
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