Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050685
Company: SI PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEDAX CEFTIBUTEN DIHYDRATE EQ 400MG BASE CAPSULE;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
12/20/1995 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050685Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/04/2010 SUPPL-12 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-11 Labeling 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/2009/050685s011,050686s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050685s011,050686s014ltr.pdf
05/19/2000 SUPPL-8 Labeling

Label is not available on this site.

07/23/1999 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/1999 SUPPL-6 Labeling

Label is not available on this site.

09/03/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/26/1996 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/21/1997 SUPPL-3 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
02/10/2009 SUPPL-11 Labeling Label (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/2009/050685s011,050686s014lbl.pdf

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