Assyro AI

Orange Book product · Generic (ANDA)

ADRIAMYCIN PFS

DOXORUBICIN HYDROCHLORIDE

Generic (ANDA)ANDA 063165DISCN PFIZER

At a glance

Jan 30, 1991

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 30, 1991

    35 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DOXORUBICIN HYDROCHLORIDE

Strength

2MG/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 063165

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

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.