Assyro AI

Orange Book product · Brand (NDA)

TAMIFLU

OSELTAMIVIR PHOSPHATE

Brand (NDA)NDA 021246DISCN ROCHE

At a glance

Dec 14, 2000

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 14, 2000

    25 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

OSELTAMIVIR PHOSPHATE

Strength

EQ 12MG BASE/ML

Dosage form

FOR SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 021246

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

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.