Orange Book product · Brand (NDA)

AZMIRO

TESTOSTERONE CYPIONATE

Brand (NDA)NDA 216318RX AZURITY

Jun 02, 2022

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 02, 2022
4 yr 1 mo ago
Today
Patent 11311554 expires
Listed drug product patent expiration.
Mar 25, 2039
in 12 yr 11 mo
Patent 11642355 expires
Listed drug product patent expiration.
Mar 25, 2039
in 12 yr 11 mo
Patent 12138271 expires
Listed drug product patent expiration.
Mar 25, 2039
in 12 yr 11 mo

Active ingredient

TESTOSTERONE CYPIONATE

Strength

200MG/ML (200MG/ML)

Dosage form

SOLUTION

Route

INTRAMUSCULAR

TE code

Not listed

Application

NDA 216318

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
11311554	Mar 25, 2039	in 12 yr 11 mo	Product
11642355	Mar 25, 2039	in 12 yr 11 mo	Product
12138271	Mar 25, 2039	in 12 yr 11 mo	Product