← FDA DRUG APPROVALS

FDA NDA · NDA200677

SIGNIFOR

pasireotide

Sponsor: RECORDATI RARE

APPLICATION
NDA200677
TYPE
NDA
ORIGINAL APPROVAL
2012-12-14
LATEST ACTION
2024-07-11
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

SIGNIFOR · ReferencePrescription
PASIREOTIDE DIASPARTATE EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML) · SOLUTION · SUBCUTANEOUS
SIGNIFOR · ReferencePrescription
PASIREOTIDE DIASPARTATE EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML) · SOLUTION · SUBCUTANEOUS
SIGNIFOR · ReferencePrescription
PASIREOTIDE DIASPARTATE EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML) · SOLUTION · SUBCUTANEOUS

Approval history

2024-07-11Labeling · Supplement 12 · standard — Label ↗AP
2020-01-15Efficacy · Supplement 6 · standard — Label ↗AP
2019-04-11Labeling · Supplement 5 · standard — Label ↗AP
2019-01-29Labeling · Supplement 4 · standard — Label ↗AP
2018-03-09Labeling · Supplement 3 · standard — Label ↗AP
2015-03-17Labeling · Supplement 2 · standard — Label ↗AP
2013-02-13Labeling · Supplement 1 · standard — Letter ↗AP
2012-12-14Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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