Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050749
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMNICEF CEFDINIR 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** FOR SUSPENSION;ORAL Discontinued None Yes No
OMNICEF CEFDINIR 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** FOR SUSPENSION;ORAL Discontinued None Yes No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
12/04/1997 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050739s000_050749s000_OmnicefTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/18/2015 SUPPL-23 Labeling-Package Insert 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/2015/050739s017,050749s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050739Orig1s017,050749Orig1s023ltr.pdf
12/15/2008 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050739s015,050749s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050739s015, 050749s021ltr.pdf
09/14/2007 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s014,050749s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050739s014, 050749s018ltr.pdf
06/15/2007 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s013,050749s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050739s013, 050749s017ltr.pdf
07/19/2005 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050739s010,050749s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050739s010,050749s013ltr.pdf
07/29/2004 SUPPL-10 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50749s010ltr.pdf
09/02/2004 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50749s009,50739s007ltr.pdf
06/18/2001 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/13/1999 SUPPL-4 Labeling

Label is not available on this site.

07/14/1999 SUPPL-2 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50749s02lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50749s02ltr.pdf
04/22/1998 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/18/2015 SUPPL-23 Labeling-Package Insert 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/2015/050739s017,050749s023lbl.pdf
12/15/2008 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050739s015,050749s021lbl.pdf
09/14/2007 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s014,050749s018lbl.pdf
06/15/2007 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s013,050749s017lbl.pdf
07/19/2005 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050739s010,050749s013lbl.pdf
07/14/1999 SUPPL-2 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50749s02lbl.pdf

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