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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050621
Company: LEDERLE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUPRAX CEFIXIME 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
SUPRAX CEFIXIME 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No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
04/28/1989 ORIG-1 Approval Type 1 - New Molecular Entity 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
05/18/2004 SUPPL-27 Labeling

Label is not available on this site.
08/20/2003 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50621slr026,50622slr020_suprax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50621slr026,50622slr020ltr.pdf
08/16/2002 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.
03/29/2004 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50621slr023,50622slr017_suprax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50621slr023,50622slr017ltr.pdf
03/13/2009 SUPPL-22 Labeling

Label is not available on this site.
02/27/1998 SUPPL-21 Labeling

Label is not available on this site.
03/13/2009 SUPPL-20 Efficacy-New Indication

Label is not available on this site.
03/10/1994 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.
03/13/2009 SUPPL-18 Labeling

Label is not available on this site.
11/13/1992 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
03/13/2009 SUPPL-16 Efficacy-New Indication

Label is not available on this site.
03/13/2009 SUPPL-15 Efficacy-New Indication

Label is not available on this site.
03/13/2009 SUPPL-14 Efficacy-New Indication

Label is not available on this site.
09/10/1992 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
02/28/1992 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/13/2009 SUPPL-11 Labeling

Label is not available on this site.
02/05/1993 SUPPL-10 Efficacy-New Indication

Label is not available on this site.
02/27/1992 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.
01/19/1993 SUPPL-8 Labeling

Label is not available on this site.
07/12/1990 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
10/31/1990 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
03/09/1992 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/13/2009 SUPPL-4 Efficacy-New Indication

Label is not available on this site.
04/18/1990 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
06/25/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
05/31/1989 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/29/2004 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50621slr023,50622slr017_suprax_lbl.pdf
08/20/2003 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50621slr026,50622slr020_suprax_lbl.pdf
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