Orange Book product · Brand (NDA)

ACULAR LS

KETOROLAC TROMETHAMINE

Brand (NDA)NDA 021528RX ABBVIE

May 30, 2003

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 30, 2003
23 yr 5 mo ago
Today
Patent 8008338 expires
Listed drug substance patent expiration.
May 24, 2027
in 11 mo
Patent 8008338*PED expires
Listed listed patent expiration.
Nov 24, 2027
in 1 yr 5 mo

Active ingredient

KETOROLAC TROMETHAMINE

Strength

0.4%

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 021528

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

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
8008338	May 24, 2027	in 11 mo	SubstanceProductU-1181
8008338*PED	Nov 24, 2027	in 1 yr 5 mo