Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021204
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STARLIX NATEGLINIDE 60MG TABLET;ORAL Prescription AB Yes No
STARLIX NATEGLINIDE 120MG TABLET;ORAL Prescription AB Yes Yes
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
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.

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

STARLIX

TABLET;ORAL; 60MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NATEGLINIDE NATEGLINIDE 60MG TABLET;ORAL Prescription No AB 205055 ALVOGEN MALTA
NATEGLINIDE NATEGLINIDE 60MG TABLET;ORAL Prescription No AB 077461 DR REDDYS LABS LTD
NATEGLINIDE NATEGLINIDE 60MG TABLET;ORAL Prescription No AB 077463 PAR PHARM
NATEGLINIDE NATEGLINIDE 60MG TABLET;ORAL Prescription No AB 077462 WATSON LABS
NATEGLINIDE NATEGLINIDE 60MG TABLET;ORAL Prescription No AB 205544 WILSHIRE PHARMS INC
NATEGLINIDE NATEGLINIDE 60MG TABLET;ORAL Prescription No AB 205248 ZYDUS PHARMS USA INC
STARLIX NATEGLINIDE 60MG TABLET;ORAL Prescription Yes AB 021204 NOVARTIS

TABLET;ORAL; 120MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NATEGLINIDE NATEGLINIDE 120MG TABLET;ORAL Prescription No AB 205055 ALVOGEN MALTA
NATEGLINIDE NATEGLINIDE 120MG TABLET;ORAL Prescription No AB 077461 DR REDDYS LABS LTD
NATEGLINIDE NATEGLINIDE 120MG TABLET;ORAL Prescription No AB 077463 PAR PHARM
NATEGLINIDE NATEGLINIDE 120MG TABLET;ORAL Prescription No AB 077462 WATSON LABS
NATEGLINIDE NATEGLINIDE 120MG TABLET;ORAL Prescription No AB 205544 WILSHIRE PHARMS INC
NATEGLINIDE NATEGLINIDE 120MG TABLET;ORAL Prescription No AB 205248 ZYDUS PHARMS USA INC
STARLIX NATEGLINIDE 120MG TABLET;ORAL Prescription Yes AB 021204 NOVARTIS

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