Orange Book product · Brand (NDA)

TRIESENCE

TRIAMCINOLONE ACETONIDE

Brand (NDA)NDA 022048RX HARROW EYE

Nov 29, 2007

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Nov 29, 2007
18 yr 10 mo ago
Today
Patent 8211880 expires
Listed method-of-use patent (U-1258) expiration.
Mar 10, 2029
in 2 yr 9 mo
Patent 8211880 expires
Listed method-of-use patent (U-1257) expiration.
Mar 10, 2029
in 2 yr 9 mo
Patent 8128960 expires
Listed drug product patent expiration.
Dec 17, 2029
in 3 yr 7 mo

Active ingredient

TRIAMCINOLONE ACETONIDE

Strength

40MG/ML (40MG/ML)

Dosage form

INJECTABLE

Route

INTRAVITREAL

TE code

Not listed

Application

NDA 022048

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
8211880	Mar 10, 2029	in 2 yr 9 mo	U-1258
8211880	Mar 10, 2029	in 2 yr 9 mo	U-1257
8128960	Dec 17, 2029	in 3 yr 7 mo	Product