Orange Book product · Brand (NDA)

SOMATULINE DEPOT

LANREOTIDE ACETATE

Brand (NDA)NDA 022074TE ABRX IPSEN PHARMA

View LANREOTIDE ACETATE family Open on FDA Orange Book

At a glance

Aug 30, 2007

Approved

Brand (NDA)

Application

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Aug 30, 2007
19 yr 1 mo ago
Today

Pharmaceutical detail

Active ingredient

LANREOTIDE ACETATE

Strength

EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)

Dosage form

SOLUTION

Route

SUBCUTANEOUS

TE code

Application

NDA 022074

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

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

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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