Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 050686
Company: SI PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEDAX CEFTIBUTEN DIHYDRATE EQ 90MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** FOR SUSPENSION;ORAL Discontinued None Yes No
CEDAX CEFTIBUTEN DIHYDRATE EQ 180MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** FOR SUSPENSION;ORAL Discontinued None Yes No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
12/20/1995 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
03/11/2011 SUPPL-16 Manufacturing (CMC) Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050686s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050686s016ltr.pdf
11/04/2010 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050685s012,050686s015ltr.pdf
02/10/2009 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050685s011,050686s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050685s011,050686s014ltr.pdf
01/04/2001 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/19/2000 SUPPL-9 Labeling

Label is not available on this site.

10/02/1998 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

06/15/1998 SUPPL-7 Labeling

Label is not available on this site.

02/16/1999 SUPPL-6 Labeling

Label is not available on this site.

03/03/1998 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/03/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/10/1996 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1997 SUPPL-2 Labeling

Label is not available on this site.

10/09/1996 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
03/11/2011 SUPPL-16 Manufacturing (CMC) Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050686s016lbl.pdf
02/10/2009 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050685s011,050686s014lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English