Orange Book product · Brand (NDA)

SIGNIFOR

PASIREOTIDE DIASPARTATE

Brand (NDA)NDA 200677RX RECORDATI RARE

Dec 14, 2012

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 14, 2012
13 yr 9 mo ago
Today
Patent 7473761 expires
Listed drug substance patent expiration.
Dec 14, 2026
in 6 mo

Active ingredient

PASIREOTIDE DIASPARTATE

Strength

EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)

Dosage form

SOLUTION

Route

SUBCUTANEOUS

TE code

Not listed

Application

NDA 200677

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7473761	Dec 14, 2026	in 6 mo	SubstanceProduct