Orange Book product · Brand (NDA)

IVRA

MELPHALAN HYDROCHLORIDE

Brand (NDA)NDA 217110RX APOTEX

Aug 18, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Aug 18, 2023
2 yr 11 mo ago
Today
Patent 10537520 expires
Listed drug product patent expiration.
Jun 29, 2036
in 10 yr 2 mo

Active ingredient

MELPHALAN HYDROCHLORIDE

Strength

EQ 90MG BASE/ML (EQ 90MG BASE/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 217110

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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
10537520	Jun 29, 2036	in 10 yr 2 mo	Product