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Orange Book product · Generic (ANDA)

DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

DOXORUBICIN HYDROCHLORIDE

Generic (ANDA)ANDA 203263TE ABRX SUN PHARM

At a glance

Feb 04, 2013

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 04, 2013

    13 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DOXORUBICIN HYDROCHLORIDE

Strength

20MG/10ML (2MG/ML)

Dosage form

INJECTABLE, LIPOSOMAL

Route

INJECTION

TE code

AB

Application

ANDA 203263

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of DOXORUBICIN 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.