Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050749
Company: ABBVIE

Products on NDA 50749

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OMNICEF	CEFDINIR	125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	FOR SUSPENSION;ORAL	Discontinued	None	Yes	No
OMNICEF	CEFDINIR	250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	FOR SUSPENSION;ORAL	Discontinued	None	Yes	No

Labels for NDA 050749

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