Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021008
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SANDOSTATIN LAR OCTREOTIDE ACETATE EQ 10MG BASE/VIAL INJECTABLE;INJECTION Prescription None Yes No
SANDOSTATIN LAR OCTREOTIDE ACETATE EQ 20MG BASE/VIAL INJECTABLE;INJECTION Prescription None Yes No
SANDOSTATIN LAR OCTREOTIDE ACETATE EQ 30MG BASE/VIAL INJECTABLE;INJECTION Prescription None 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
11/25/1998 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/21008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/21008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/021008.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/11/2019 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021008s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021008Orig1s043ltr.pdf
03/30/2021 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021008s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021008Orig1s041ltr.pdf
12/21/2018 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021008Orig1s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021008Orig1s036Ltr.pdf
07/22/2016 SUPPL-35 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021008s035lbl.pdf
05/20/2016 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

05/18/2015 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

08/21/2014 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

07/17/2014 SUPPL-30 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021008s030lbl.pdf
01/30/2014 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

05/19/2014 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021008s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021008Orig1s028ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021008Orig1s028.pdf
11/30/2012 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

09/30/2011 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021008s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021008s025ltr.pdf
01/25/2010 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019667s058,021008s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019667s058,021008s023ltr.pdf
03/03/2008 SUPPL-21 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021008s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021008s021ltr.pdf
05/10/2006 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021008s018s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021008s018,s019ltr.pdf
05/10/2006 SUPPL-18 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021008s018s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021008s018,s019ltr.pdf
10/14/2004 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21008s015ltr.pdf
04/19/2004 SUPPL-10 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21008scs010_sandostatin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21008scs010ltr.pdf
12/18/2003 SUPPL-7 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21008scs007ltr.pdf
04/19/2004 SUPPL-6 Labeling

Label is not available on this site.

05/13/2002 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/03/2002 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/02/2001 SUPPL-3 Labeling

Label is not available on this site.

07/13/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/17/1999 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/30/2021 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021008s041lbl.pdf
04/11/2019 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021008s043lbl.pdf
12/21/2018 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021008Orig1s036lbl.pdf
07/22/2016 SUPPL-35 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021008s035lbl.pdf
07/17/2014 SUPPL-30 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021008s030lbl.pdf
05/19/2014 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021008s028lbl.pdf
09/30/2011 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021008s025lbl.pdf
01/25/2010 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019667s058,021008s023lbl.pdf
03/03/2008 SUPPL-21 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021008s021lbl.pdf
05/10/2006 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021008s018s019lbl.pdf
05/10/2006 SUPPL-18 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021008s018s019lbl.pdf
04/19/2004 SUPPL-10 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21008scs010_sandostatin_lbl.pdf
11/25/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/21008lbl.pdf

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