← FDA DRUG APPROVALS

FDA NDA · NDA022074

SOMATULINE DEPOT

lanreotide acetate

Sponsor: IPSEN PHARMA

APPLICATION
NDA022074
TYPE
NDA
ORIGINAL APPROVAL
2007-08-30
LATEST ACTION
2024-07-11
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

SOMATULINE DEPOT · ReferencePrescription
LANREOTIDE ACETATE EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) · SOLUTION · SUBCUTANEOUS
SOMATULINE DEPOT · ReferencePrescription
LANREOTIDE ACETATE EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) · SOLUTION · SUBCUTANEOUS
SOMATULINE DEPOT · ReferencePrescription
LANREOTIDE ACETATE EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) · SOLUTION · SUBCUTANEOUS

Approval history

2024-07-11Labeling · Supplement 32 · standard — Letter ↗AP
2023-02-24Manufacturing (CMC) · Supplement 26 · standard — Label ↗AP
2019-06-14Manufacturing (CMC) · Supplement 21 — Letter ↗AP
2019-04-11Labeling · Supplement 24 · 901 required — Label ↗AP
2018-12-12Labeling · Supplement 22 · standard — Letter ↗AP
2018-02-22Labeling · Supplement 18 · standard — Label ↗AP
2017-10-23Manufacturing (CMC) · Supplement 20AP
2017-09-15Efficacy · Supplement 17 · standard — Label ↗AP
2015-12-11Manufacturing (CMC) · Supplement 15 · standardAP
2015-11-02Manufacturing (CMC) · Supplement 14 · standardAP
2015-06-01Manufacturing (CMC) · Supplement 12 · standardAP
2015-06-01Manufacturing (CMC) · Supplement 13 · standardAP
2014-12-22Labeling · Supplement 10 · standard — Letter ↗AP
2014-12-16Efficacy · Supplement 11 · priority — Letter ↗AP
2014-10-28Manufacturing (CMC) · Supplement 4 · standard — Review ↗AP
2014-10-23Manufacturing (CMC) · Supplement 9 · standard — Review ↗AP
2014-02-21Manufacturing (CMC) · Supplement 7 · standard — Review ↗AP
2013-11-27Labeling · Supplement 6 · standard — Label ↗AP
2011-03-04Efficacy · Supplement 3 · standard — Label ↗AP
2007-08-30Type 1 - New Molecular Entity · Original · standard — Review ↗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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