Assyro AI

Orange Book product · Generic (ANDA)

KETOPROFEN

KETOPROFEN

Generic (ANDA)ANDA 074879DISCN ALKERMES GAINESVILLE

At a glance

Dec 10, 1997

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 10, 1997

    28 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

KETOPROFEN

Strength

200MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

ANDA 074879

Product number

001

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.