Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019667
Company: NOVARTIS
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| OCTREOTIDE ACETATE | EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| SANDOSTATIN | OCTREOTIDE ACETATE | EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
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 |
|---|---|---|---|---|---|
| 11/03/2023 | SUPPL-76 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019667s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019667Orig1s076ltr.pdf | |
| 10/04/2022 | SUPPL-73 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019667s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019667Orig1s073ltr.pdf | |
| 10/20/2021 | SUPPL-71 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019667Orig1s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019667Orig1s071ltr.pdf | |
| 05/25/2021 | SUPPL-70 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019667s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019667Orig1s070ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 11/03/2023 | SUPPL-76 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019667s076lbl.pdf | |
| 11/03/2023 | SUPPL-76 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019667s076lbl.pdf | |
| 10/04/2022 | SUPPL-73 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019667s073lbl.pdf | |
| 10/20/2021 | SUPPL-71 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019667Orig1s071lbl.pdf | |
| 05/25/2021 | SUPPL-70 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019667s070lbl.pdf | |
| 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 |
| OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075957 | MEITHEAL |
| 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 | 216839 | GLAND PHARMA LTD |
| OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 0.1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204669 | HERITAGE PHARMS |
| OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 0.1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075957 | MEITHEAL |
| 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 | 216839 | GLAND PHARMA LTD |
| OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 0.5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204669 | HERITAGE PHARMS |
| OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 0.5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075957 | MEITHEAL |
| 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 |