Orange Book product · Brand (NDA)

KYTRIL

GRANISETRON HYDROCHLORIDE

Brand (NDA)NDA 020305DISCN ROCHE

View GRANISETRON HYDROCHLORIDE family Open on FDA Orange Book

At a glance

Mar 16, 1995

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Mar 16, 1995
31 yr 9 mo ago
Today

Pharmaceutical detail

Active ingredient

GRANISETRON HYDROCHLORIDE

Strength

EQ 1MG BASE **Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons**

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 020305

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

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.

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

Book a Demo