Orange Book product · Brand (NDA)

RIZAFILM

RIZATRIPTAN BENZOATE

Brand (NDA)NDA 205394DISCN GENSCO

Apr 14, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 14, 2023
3 yr 3 mo ago
Today
Patent 9301948 expires
Listed drug substance patent expiration.
Jul 30, 2034
in 8 yr 3 mo

Active ingredient

RIZATRIPTAN BENZOATE

Strength

EQ 10MG BASE

Dosage form

FILM

Route

ORAL

TE code

Not listed

Application

NDA 205394

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

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

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9301948	Jul 30, 2034	in 8 yr 3 mo	SubstanceProduct