Assyro AI

Orange Book product · Generic (ANDA)

KETOPROFEN

KETOPROFEN

Generic (ANDA)ANDA 075270DISCN ACTAVIS LABS FL INC

At a glance

Mar 24, 1999

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 24, 1999

    27 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

KETOPROFEN

Strength

100MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

ANDA 075270

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of KETOPROFEN

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.