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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050622
Company: LEDERLE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUPRAX CEFIXIME 100MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION;ORAL Discontinued None Yes No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 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
05/18/2004 SUPPL-21 Labeling

Label is not available on this site.
08/20/2003 SUPPL-20 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
08/06/2002 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
03/29/2004 SUPPL-17 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
03/15/2001 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.
03/13/2009 SUPPL-15 Labeling

Label is not available on this site.
02/06/2001 SUPPL-14 Labeling

Label is not available on this site.
02/27/1998 SUPPL-13 Labeling

Label is not available on this site.
03/09/1994 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
04/22/1993 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/13/2009 SUPPL-10 Labeling

Label is not available on this site.
09/10/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
03/13/2009 SUPPL-8 Labeling

Label is not available on this site.
03/09/1992 SUPPL-7 Labeling

Label is not available on this site.
12/05/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
01/19/1993 SUPPL-5 Labeling

Label is not available on this site.
06/25/1991 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
03/13/2009 SUPPL-3 Labeling

Label is not available on this site.
03/30/1990 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-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50621slr023,50622slr017_suprax_lbl.pdf
08/20/2003 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50621slr026,50622slr020_suprax_lbl.pdf
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