Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021008
Company: NOVARTIS
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 | AB | Yes | No |
| SANDOSTATIN LAR | OCTREOTIDE ACETATE | EQ 20MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AB | Yes | No |
| SANDOSTATIN LAR | OCTREOTIDE ACETATE | EQ 30MG BASE/VIAL | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 01/05/2024 | SUPPL-47 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021008Orig1s047Corrected_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021008Orig1s047Corrected_ltr.pdf | |
| 02/09/2023 | SUPPL-46 | Manufacturing (CMC)-Facility |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021008Orig1s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021008Orig1s046ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 01/05/2024 | SUPPL-47 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021008Orig1s047Corrected_lbl.pdf | |
| 01/05/2024 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021008Orig1s047Corrected_lbl.pdf | |
| 02/09/2023 | SUPPL-46 | Manufacturing (CMC)-Facility | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021008Orig1s046lbl.pdf | |
| 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 |
SANDOSTATIN LAR
INJECTABLE;INJECTION; EQ 10MG BASE/VIAL
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 10MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AB | 210317 | TEVA PHARMS USA INC |
| SANDOSTATIN LAR | OCTREOTIDE ACETATE | EQ 10MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AB | 021008 | NOVARTIS |
INJECTABLE;INJECTION; EQ 20MG BASE/VIAL
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 20MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AB | 210317 | TEVA PHARMS USA INC |
| SANDOSTATIN LAR | OCTREOTIDE ACETATE | EQ 20MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AB | 021008 | NOVARTIS |
INJECTABLE;INJECTION; EQ 30MG BASE/VIAL
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 30MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AB | 210317 | TEVA PHARMS USA INC |
| SANDOSTATIN LAR | OCTREOTIDE ACETATE | EQ 30MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AB | 021008 | NOVARTIS |