Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 021204
Company: NOVARTIS

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
STARLIX	NATEGLINIDE	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
STARLIX	NATEGLINIDE	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Url
10/28/2021	SUPPL-25	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021204s025lbl.pdf
05/10/2018	SUPPL-23	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021204s023lbl.pdf
03/14/2017	SUPPL-15	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021204s015lbl.pdf
08/24/2011	SUPPL-14	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021204s014lbl.pdf
07/15/2008	SUPPL-11	Labeling	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021204s011lbl.pdf
11/09/2006	SUPPL-10	Labeling	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021204s010lbl.pdf
07/01/2004	SUPPL-9	Labeling	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21204slr009_starlix_lbl.pdf
10/20/2003	SUPPL-6	Efficacy-New Indication	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21204se1-006_starlix_lbl.pdf
11/26/2002	SUPPL-5	Labeling	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21204slr005_Starlix_lbl.pdf
12/22/2000	ORIG-1	Approval	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21204lbl.pdf