Assyro AI

Orange Book product · Generic (ANDA)

MELPHALAN HYDROCHLORIDE

MELPHALAN HYDROCHLORIDE

Generic (ANDA)ANDA 090303TE APRX HIKMA

At a glance

Oct 28, 2010

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 28, 2010

    15 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

MELPHALAN HYDROCHLORIDE

Strength

EQ 50MG BASE/VIAL

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 090303

Product number

001

Marketing status

RX

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.