Assyro AI

Orange Book product · Generic (ANDA)

KETOROLAC TROMETHAMINE

KETOROLAC TROMETHAMINE

Generic (ANDA)ANDA 078399DISCN EPIC PHARMA LLC

At a glance

Nov 05, 2009

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 05, 2009

    16 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

KETOROLAC TROMETHAMINE

Strength

0.4%

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

ANDA 078399

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of KETOROLAC TROMETHAMINE

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.