Orange Book product · Brand (NDA)

TOPOTECAN HYDROCHLORIDE

Brand (NDA)NDA 022453DISCN MEITHEAL

View TOPOTECAN HYDROCHLORIDE family Open on FDA Orange Book

At a glance

Dec 20, 2012

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Dec 20, 2012
13 yr 8 mo ago
Today

Pharmaceutical detail

Active ingredient

TOPOTECAN HYDROCHLORIDE

Strength

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 022453

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Reference standard (RS)

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.

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

Book a Demo