Orange Book product · Brand (NDA)

TOBRADEX ST

DEXAMETHASONE; TOBRAMYCIN

Brand (NDA)NDA 050818RX HARROW EYE

Feb 13, 2009

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 13, 2009
17 yr 7 mo ago
Today
Patent 8101582 expires
Listed drug product patent expiration.
Dec 19, 2027
in 1 yr 6 mo
Patent 8450287 expires
Listed drug product patent expiration.
Dec 19, 2027
in 1 yr 6 mo
Patent 7795316 expires
Listed drug product patent expiration.
Aug 03, 2028
in 2 yr 2 mo

Active ingredient

DEXAMETHASONE; TOBRAMYCIN

Strength

0.05%;0.3%

Dosage form

SUSPENSION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 050818

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
8101582	Dec 19, 2027	in 1 yr 6 mo	ProductU-1082
8450287	Dec 19, 2027	in 1 yr 6 mo	Product
7795316	Aug 03, 2028	in 2 yr 2 mo	ProductU-1082