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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021204
Company: NOVARTIS

Products on NDA 021204

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STARLIX	NATEGLINIDE	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
STARLIX	NATEGLINIDE	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021204

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/2000	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21204lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21204ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-204_Stsrlix.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/28/2021	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021204s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021204Orig1s025ltr.pdf
05/10/2018	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021204s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021204Orig1s023ltr.pdf
11/30/2016	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
04/07/2016	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
12/02/2015	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
03/14/2017	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021204s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021204Orig1s015ltr.pdf
08/24/2011	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021204s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021204s014ltr.pdf
07/15/2008	SUPPL-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021204s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021204s011ltr.pdf
11/09/2006	SUPPL-10	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021204s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021204s010LTR.pdf
07/01/2004	SUPPL-9	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21204slr009_starlix_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21204slr009ltr.pdf
10/20/2003	SUPPL-6	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21204se1-006_starlix_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21204se1-006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021204_S006_STARLIX_TABS_AP.pdf
11/26/2002	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21204slr005_Starlix_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21204slr005ltr.pdf
09/25/2002	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
02/27/2002	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
01/03/2002	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/01/2001	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 021204

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	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

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