Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019667
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SANDOSTATIN OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription AP Yes Yes
SANDOSTATIN OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE;INJECTION Prescription AP Yes Yes
SANDOSTATIN OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE;INJECTION Prescription AP Yes Yes
SANDOSTATIN OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE;INJECTION Prescription AP Yes Yes
SANDOSTATIN OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription AP 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
10/21/1988 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/11/2019 SUPPL-67 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019667s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019667Orig1s067ltr.pdf
02/21/2015 SUPPL-62 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019667Orig1s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019667Orig1s062ltr.pdf
03/23/2012 SUPPL-61 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019667s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019667s061ltr.pdf
02/04/2014 SUPPL-59 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019667Orig1s059ltr.pdf
01/25/2010 SUPPL-58 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
08/26/2008 SUPPL-54 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019667s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019653Orig1s058,19697Orig1s054ltr.pdf
09/02/2005 SUPPL-50 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019667s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019667s050ltr.pdf
01/17/2003 SUPPL-44 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19667scm044_Sandostatin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19667scm044ltr.pdf
05/28/2002 SUPPL-43 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/10/2003 SUPPL-42 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19667scm042ltr.pdf
05/13/2002 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

01/03/2002 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

06/21/2001 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

07/02/2001 SUPPL-38 Labeling

Label is not available on this site.

02/17/1999 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

02/17/1999 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

07/31/1998 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

12/17/1998 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/2002 SUPPL-32 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19667slr028,032ltr.pdf
10/24/1997 SUPPL-31 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/24/1997 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

10/24/1997 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/2002 SUPPL-28 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19667slr028,032ltr.pdf
10/24/1997 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

10/21/1996 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/1996 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

07/16/1996 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/1996 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/16/1996 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/1994 SUPPL-21 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/18/1995 SUPPL-20 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/06/1995 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/1994 SUPPL-17 Efficacy-New Indication

Label is not available on this site.

01/12/1993 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1992 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/31/1992 SUPPL-14 Labeling

Label is not available on this site.

10/10/1995 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/1995 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1992 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

10/04/1991 SUPPL-8 Labeling

Label is not available on this site.

07/03/1991 SUPPL-7 Labeling

Label is not available on this site.

04/16/1990 SUPPL-5 Labeling

Label is not available on this site.

06/12/1991 SUPPL-4 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019667-s04.pdf
06/23/1989 SUPPL-3 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
04/11/2019 SUPPL-67 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019667s067lbl.pdf
02/21/2015 SUPPL-62 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019667Orig1s062lbl.pdf
03/23/2012 SUPPL-61 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019667s061lbl.pdf
01/25/2010 SUPPL-58 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019667s058,021008s023lbl.pdf
08/26/2008 SUPPL-54 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019667s054lbl.pdf
09/02/2005 SUPPL-50 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019667s050lbl.pdf
01/17/2003 SUPPL-44 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19667scm044_Sandostatin_lbl.pdf

SANDOSTATIN

INJECTABLE;INJECTION; EQ 0.05MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription No AP 204669 HERITAGE PHARMS INC
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription No AP 075957 TEVA PHARMS USA
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription No AP 077457 FRESENIUS KABI USA
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription No AP 079198 MYLAN INSTITUTIONAL
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription No AP 090834 SAGENT PHARMS INC
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076313 WEST-WARD PHARMS INT
SANDOSTATIN OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 019667 NOVARTIS

INJECTABLE;INJECTION; EQ 0.1MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 204669 HERITAGE PHARMS INC
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 075957 TEVA PHARMS USA
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 077457 FRESENIUS KABI USA
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 079198 MYLAN INSTITUTIONAL
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 090834 SAGENT PHARMS INC
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076313 WEST-WARD PHARMS INT
SANDOSTATIN OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 019667 NOVARTIS

INJECTABLE;INJECTION; EQ 0.5MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 204669 HERITAGE PHARMS INC
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 075957 TEVA PHARMS USA
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 077457 FRESENIUS KABI USA
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 079198 MYLAN INSTITUTIONAL
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 090834 SAGENT PHARMS INC
OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076313 WEST-WARD PHARMS INT
SANDOSTATIN OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 019667 NOVARTIS

INJECTABLE;INJECTION; EQ 0.2MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 077450 FRESENIUS KABI USA
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 091041 SAGENT PHARMS INC
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 075959 TEVA PHARMS USA
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076330 WEST-WARD PHARMS INT
SANDOSTATIN OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 019667 NOVARTIS

INJECTABLE;INJECTION; EQ 1MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 077450 FRESENIUS KABI USA
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 091041 SAGENT PHARMS INC
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 075959 TEVA PHARMS USA
OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076330 WEST-WARD PHARMS INT
SANDOSTATIN OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 019667 NOVARTIS

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