Orange Book product · Brand (NDA)

TRIPTODUR KIT

TRIPTORELIN PAMOATE

Brand (NDA)NDA 208956RX AZURITY

Jun 29, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 29, 2017
9 yr 1 mo ago
Today
Patent 10166181 expires
Listed drug product patent expiration.
Jun 30, 2029
in 3 yr 1 mo

Active ingredient

TRIPTORELIN PAMOATE

Strength

EQ 22.5MG BASE/VIAL

Dosage form

FOR SUSPENSION, EXTENDED RELEASE

Route

INTRAMUSCULAR

TE code

Not listed

Application

NDA 208956

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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
10166181	Jun 30, 2029	in 3 yr 1 mo	Product