Orange Book product · Brand (NDA)

AVEED

TESTOSTERONE UNDECANOATE

Brand (NDA)NDA 022219RX ENDO OPERATIONS

Mar 05, 2014

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 05, 2014
12 yr 6 mo ago
Today
Patent 7718640 expires
Listed drug product patent expiration.
Mar 14, 2027
in 9 mo
Patent 8338395 expires
Listed method-of-use patent (U-1500) expiration.
May 08, 2027
in 11 mo

Active ingredient

TESTOSTERONE UNDECANOATE

Strength

750MG/3ML (250MG/ML)

Dosage form

INJECTABLE

Route

INTRAMUSCULAR

TE code

Not listed

Application

NDA 022219

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
7718640	Mar 14, 2027	in 9 mo	Product
8338395	May 08, 2027	in 11 mo	U-1500