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Orange Book product · Generic (ANDA)

MELPHALAN HYDROCHLORIDE

MELPHALAN HYDROCHLORIDE

Generic (ANDA)ANDA 210947DISCN INGENUS PHARMS LLC

At a glance

Feb 18, 2020

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 18, 2020

    6 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

MELPHALAN HYDROCHLORIDE

Strength

EQ 50MG BASE/VIAL

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 210947

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of MELPHALAN HYDROCHLORIDE

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

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