Assyro AI

Orange Book product · Brand (NDA)

FLO-PRED

PREDNISOLONE ACETATE

Brand (NDA)NDA 022067DISCN SUN PHARMA CANADA

At a glance

Jan 17, 2008

Approved

Brand (NDA)

Application

Not listed

TE code

2

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 17, 2008

    18 yr 8 mo ago

  2. Today

  3. Patent 7799331 expires

    Listed drug product patent expiration.

    Oct 11, 2028

    in 2 yr 4 mo

  4. Patent 7799331 expires

    Listed drug product patent expiration.

    Oct 11, 2028

    in 2 yr 4 mo

Pharmaceutical detail

Active ingredient

PREDNISOLONE ACETATE

Strength

EQ 5MG BASE/5ML

Dosage form

SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 022067

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7799331Oct 11, 2028in 2 yr 4 mo
ProductU-1068
7799331Oct 11, 2028in 2 yr 4 mo
ProductU-139
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.