Drugs@FDA: FDA Approved Drug Products

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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SUPRAX CEFIXIME 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
SUPRAX CEFIXIME 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
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
02/27/1998 SUPPL-21 Labeling

Label is not available on this site.

03/10/1994 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

11/13/1992 SUPPL-17 Manufacturing (CMC)

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.

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.

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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