Assyro AI

Orange Book product · Generic (ANDA)

TAB-PROFEN

IBUPROFEN

Generic (ANDA)ANDA 072095DISCN PERRIGO

At a glance

Dec 08, 1987

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 08, 1987

    39 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

IBUPROFEN

Strength

200MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 072095

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of IBUPROFEN

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.