← FDA DRUG APPROVALS

FDA NDA · NDA019667

SANDOSTATIN

octreotide acetate

Sponsor: NOVARTIS

APPLICATION
NDA019667
TYPE
NDA
ORIGINAL APPROVAL
1988-10-21
LATEST ACTION
2024-07-11
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

SANDOSTATIN · ReferenceDiscontinued
OCTREOTIDE ACETATE EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
SANDOSTATIN · ReferencePrescription
OCTREOTIDE ACETATE EQ 0.5MG BASE/ML · INJECTABLE · INJECTION
SANDOSTATIN · ReferencePrescription
OCTREOTIDE ACETATE EQ 0.05MG BASE/ML · INJECTABLE · INJECTION
SANDOSTATIN · ReferenceDiscontinued
OCTREOTIDE ACETATE EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
SANDOSTATIN · ReferencePrescription
OCTREOTIDE ACETATE EQ 0.1MG BASE/ML · INJECTABLE · INJECTION

Approval history

2024-07-11Labeling · Supplement 78 · standard — Letter ↗AP
2023-11-03Labeling · Supplement 76 · standard — Letter ↗AP
2022-10-04Labeling · Supplement 73 · standard — Letter ↗AP
2021-10-20Labeling · Supplement 71 · standard — Letter ↗AP
2021-05-25Labeling · Supplement 70 · standard — Letter ↗AP
2019-04-11Labeling · Supplement 67 · 901 required — Label ↗AP
2015-02-21Labeling · Supplement 62 · standard — Label ↗AP
2014-02-04Manufacturing (CMC) · Supplement 59 · priority — Letter ↗AP
2012-03-23Labeling · Supplement 61 · standard — Letter ↗AP
2010-01-25Labeling · Supplement 58 · standard — Letter ↗AP
2008-08-26Labeling · Supplement 54 · standard — Label ↗AP
2005-09-02Labeling · Supplement 50 · standard — Letter ↗AP
2003-02-10Manufacturing (CMC) · Supplement 42 · priority — Letter ↗AP
2003-01-17Manufacturing (CMC) · Supplement 44 · priority — Label ↗AP
2002-07-24Labeling · Supplement 32 · standard — Letter ↗AP
2002-07-24Labeling · Supplement 28 · standard — Letter ↗AP
2002-05-28Manufacturing (CMC) · Supplement 43 · priorityAP
2002-05-13Manufacturing (CMC) · Supplement 41 · priorityAP
2002-01-03Manufacturing (CMC) · Supplement 40 · priorityAP
2001-07-02Labeling · Supplement 38 · standardAP
2001-06-21Manufacturing (CMC) · Supplement 39 · priorityAP
1999-02-17Manufacturing (CMC) · Supplement 35 · priorityAP
1999-02-17Manufacturing (CMC) · Supplement 36 · priorityAP
1998-12-17Manufacturing (CMC) · Supplement 33 · priorityAP
1998-07-31Manufacturing (CMC) · Supplement 34 · priorityAP
1997-10-24Manufacturing (CMC) · Supplement 30 · priorityAP
1997-10-24Manufacturing (CMC) · Supplement 29 · priorityAP
1997-10-24Manufacturing (CMC) · Supplement 27 · priorityAP
1997-10-24Manufacturing (CMC) · Supplement 31 · priorityAP
1996-10-21Manufacturing (CMC) · Supplement 26 · priorityAP
1996-08-14Manufacturing (CMC) · Supplement 25 · priorityAP
1996-07-16Manufacturing (CMC) · Supplement 24 · priorityAP
1996-06-12Manufacturing (CMC) · Supplement 23 · priorityAP
1996-02-16Manufacturing (CMC) · Supplement 22 · priorityAP
1995-12-18Manufacturing (CMC) · Supplement 20 · priorityAP
1995-11-07Manufacturing (CMC) · Supplement 11 · priorityAP
1995-10-10Manufacturing (CMC) · Supplement 12 · priorityAP
1995-02-06Manufacturing (CMC) · Supplement 19 · priorityAP
1994-12-06Manufacturing (CMC) · Supplement 21 · priorityAP
1994-05-03Efficacy · Supplement 17 · standardAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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