Assyro AI

Orange Book product · Brand (NDA)

TAMIFLU

OSELTAMIVIR PHOSPHATE

Brand (NDA)NDA 021246TE ABRX ROCHE
View OSELTAMIVIR PHOSPHATE familyOpen on FDA Orange Book

At a glance

Mar 21, 2011

Approved

Brand (NDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 21, 2011

    15 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

OSELTAMIVIR PHOSPHATE

Strength

EQ 6MG BASE/ML

Dosage form

FOR SUSPENSION

Route

ORAL

TE code

AB

Application

NDA 021246

Product number

002

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this 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

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