Assyro AI

Orange Book product · Generic (ANDA)

PREDNISONE

PREDNISONE

Generic (ANDA)ANDA 040538DISCN HIKMA PHARMS

At a glance

Jan 08, 2004

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 08, 2004

    22 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

PREDNISONE

Strength

2.5MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 040538

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of PREDNISONE

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.