Assyro AI

Orange Book product · Brand (NDA)

TAMIFLU

OSELTAMIVIR PHOSPHATE

Brand (NDA)NDA 021087DISCN ROCHE
View OSELTAMIVIR PHOSPHATE familyOpen on FDA Orange Book

At a glance

Jul 02, 2007

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 02, 2007

    19 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

OSELTAMIVIR PHOSPHATE

Strength

EQ 45MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 021087

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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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