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Orange Book product · Generic (ANDA)

EPIRUBICIN HYDROCHLORIDE

EPIRUBICIN HYDROCHLORIDE

Generic (ANDA)ANDA 065361TE APRX CIPLA LTD
View EPIRUBICIN HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Oct 22, 2007

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 22, 2007

    18 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

EPIRUBICIN HYDROCHLORIDE

Strength

50MG/25ML (2MG/ML)

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 065361

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of EPIRUBICIN 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.

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