Drugs@FDA: FDA-Approved Drugs
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. |
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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. |
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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. |
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04/08/1976 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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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 |