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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050739
Company: ABBVIE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMNICEF CEFDINIR 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE;ORAL Discontinued None Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/18/2015 SUPPL-17 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-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050739s015,050749s021lbl.pdf
09/14/2007 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s014,050749s018lbl.pdf
06/15/2007 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s013,050749s017lbl.pdf
07/19/2005 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050739s010,050749s013lbl.pdf
11/08/1999 SUPPL-2 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50739S2LBL.PDF
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