Assyro AI

Orange Book product · Generic (ANDA)

PREDNISOLONE

PREDNISOLONE

Generic (ANDA)ANDA 040570DISCN PHARM ASSOC

At a glance

Aug 25, 2005

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 25, 2005

    21 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

PREDNISOLONE

Strength

5MG/5ML

Dosage form

SYRUP

Route

ORAL

TE code

Not listed

Application

ANDA 040570

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of PREDNISOLONE

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.