Treats metastatic carcinoid tumors. NDA 19667, held by Novartis. Octreotide Acetate.
As of Nov 13, 2026, NDA 19667 (Sandostatin), held by Novartis, was first approved by FDA on Oct 21, 1988, with 49 approved supplements and 0 published complete response letters.
Sandostatin Injection is a somatostatin analogue indicated: Acromegaly: To reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. Carcinoid Tumors: For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. Vasoactive Intestinal Peptide Tumors (VIPomas): For the treatment of profuse watery diarrhea associated with VIP-secreting tumors.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 3, 1994 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | None posted |
| Oct 21, 1988 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| SandostatinEQ 0.05MG BASE/ML · injectable;injection | Octreotide Acetate | RxReference drug |
| SandostatinEQ 0.1MG BASE/ML · injectable;injection | Octreotide Acetate | RxReference drug |
| SandostatinEQ 0.5MG BASE/ML · injectable;injection | Octreotide Acetate | RxReference drug |
| SandostatinEQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Octreotide Acetate | DiscontinuedReference drug |
| SandostatinEQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Octreotide Acetate | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 11, 2024 | Supplement 78Labeling · Standard review | Approved | |
| Nov 3, 2023 | Supplement 76Labeling · Standard review | Approved | |
| Oct 4, 2022 | Supplement 73Labeling · Standard review | Approved | |
| Oct 20, 2021 | Supplement 71Labeling · Standard review | Approved | |
| May 25, 2021 | Supplement 70Labeling · Standard review | Approved | |
| Apr 11, 2019 | Supplement 67Labeling | Approved | |
| Feb 21, 2015 | Supplement 62Labeling · Standard review | Approved | |
| Feb 4, 2014 | Supplement 59Manufacturing · Priority review | Approved | |
| Mar 23, 2012 | Supplement 61Labeling · Standard review | Approved | |
| Jan 25, 2010 | Supplement 58Labeling · Standard review | Approved | |
| Aug 26, 2008 | Supplement 54Labeling · Standard review | Approved | |
| Sep 2, 2005 | Supplement 50Labeling · Standard review | Approved | |
| Feb 10, 2003 | Supplement 42Manufacturing · Priority review | Approved | |
| Jan 17, 2003 | Supplement 44Manufacturing · Priority review | Approved | |
| Jul 24, 2002 | Supplement 32Labeling · Standard review | Approved | |
| Jul 24, 2002 | Supplement 28Labeling · Standard review | Approved | |
| May 28, 2002 | Supplement 43Manufacturing · Priority review | Approved | None posted |
| May 13, 2002 | Supplement 41Manufacturing · Priority review | Approved | None posted |
| Jan 3, 2002 | Supplement 40Manufacturing · Priority review | Approved | None posted |
| Jul 2, 2001 | Supplement 38Labeling · Standard review | Approved | None posted |
| Jun 21, 2001 | Supplement 39Manufacturing · Priority review | Approved | None posted |
| Feb 17, 1999 | Supplement 35Manufacturing · Priority review | Approved | None posted |
| Feb 17, 1999 | Supplement 36Manufacturing · Priority review | Approved | None posted |
| Dec 17, 1998 | Supplement 33Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1998 | Supplement 34Manufacturing · Priority review | Approved | None posted |
| Oct 24, 1997 | Supplement 31Manufacturing · Priority review | Approved | None posted |
| Oct 24, 1997 | Supplement 30Manufacturing · Priority review | Approved | None posted |
| Oct 24, 1997 | Supplement 29Manufacturing · Priority review | Approved | None posted |
| Oct 24, 1997 | Supplement 27Manufacturing · Priority review | Approved | None posted |
| Oct 21, 1996 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| Aug 14, 1996 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| Jul 16, 1996 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Jun 12, 1996 | Supplement 23Manufacturing · Priority review | Approved | None posted |
| Feb 16, 1996 | Supplement 22Manufacturing · Priority review | Approved | None posted |
| Dec 18, 1995 | Supplement 20Manufacturing · Priority review | Approved | None posted |
| Nov 7, 1995 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Oct 10, 1995 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Feb 6, 1995 | Supplement 19Manufacturing · Priority review | Approved | None posted |
| Dec 6, 1994 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| May 3, 1994 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | None posted |
| Jan 12, 1993 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Sep 30, 1992 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1992 | Supplement 14Labeling | Approved | None posted |
| Feb 28, 1992 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Oct 4, 1991 | Supplement 8Labeling | Approved | None posted |
| Jul 3, 1991 | Supplement 7Labeling | Approved | None posted |
| Jun 12, 1991 | Supplement 4Manufacturing · Priority review | Approved | |
| Apr 16, 1990 | Supplement 5Labeling | Approved | None posted |
| Jun 23, 1989 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Oct 21, 1988 | Original applicationNew molecular entity · Priority review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
