← FDA DRUG APPROVALS

FDA NDA · NDA021008

SANDOSTATIN LAR DEPOT

octreotide acetate

Sponsor: NOVARTIS

APPLICATION
NDA021008
TYPE
NDA
ORIGINAL APPROVAL
1998-11-25
LATEST ACTION
2024-07-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

SANDOSTATIN LAR · ReferencePrescription
OCTREOTIDE ACETATE EQ 20MG BASE/VIAL · INJECTABLE · INJECTION
SANDOSTATIN LAR · ReferencePrescription
OCTREOTIDE ACETATE EQ 30MG BASE/VIAL · INJECTABLE · INJECTION
SANDOSTATIN LAR · ReferencePrescription
OCTREOTIDE ACETATE EQ 10MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

2024-07-11Labeling · Supplement 49 · standard — Letter ↗AP
2024-01-05Labeling · Supplement 47 · standard — Letter ↗AP
2023-02-09Manufacturing (CMC) · Supplement 46 — Label ↗AP
2021-03-30Labeling · Supplement 41 · standard — Letter ↗AP
2019-04-11Labeling · Supplement 43 · 901 required — Label ↗AP
2018-12-21Labeling · Supplement 36 · standard — Label ↗AP
2016-07-22Manufacturing (CMC) · Supplement 35 · priority — Label ↗AP
2016-05-20Manufacturing (CMC) · Supplement 34 · priorityAP
2015-05-18Manufacturing (CMC) · Supplement 33 · priorityAP
2014-08-21Manufacturing (CMC) · Supplement 32 · priorityAP
2014-07-17Manufacturing (CMC) · Supplement 30 · priority — Label ↗AP
2014-05-19Labeling · Supplement 28 · standard — Label ↗AP
2014-01-30Manufacturing (CMC) · Supplement 29 · priorityAP
2012-11-30Manufacturing (CMC) · Supplement 27 · priorityAP
2011-09-30Labeling · Supplement 25 · standard — Letter ↗AP
2010-01-25Labeling · Supplement 23 · standard — Label ↗AP
2008-03-03Efficacy · Supplement 21 · unknown — Letter ↗AP
2006-05-10Labeling · Supplement 19 · standard — Label ↗AP
2006-05-10Efficacy · Supplement 18 · priority — Pediatric Medical Review ↗AP
2004-10-14Labeling · Supplement 15 · standard — Letter ↗AP
2004-04-19Manufacturing (CMC) · Supplement 10 · priority — Letter ↗AP
2004-04-19Labeling · Supplement 6 · standardAP
2003-12-18Manufacturing (CMC) · Supplement 7 · priority — Letter ↗AP
2002-05-13Manufacturing (CMC) · Supplement 5 · priorityAP
2002-01-03Manufacturing (CMC) · Supplement 4 · priorityAP
2001-07-02Labeling · Supplement 3 · standardAP
1999-07-13Manufacturing (CMC) · Supplement 2 · priorityAP
1999-05-17Labeling · Supplement 1 · standardAP
1998-11-25Type 3 - New Dosage Form · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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