Assyro AI

Orange Book product · Generic (ANDA)

CEFEPIME HYDROCHLORIDE

CEFEPIME HYDROCHLORIDE

Generic (ANDA)ANDA 065441TE APRX ACS DOBFAR

At a glance

Mar 20, 2008

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 20, 2008

    18 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CEFEPIME HYDROCHLORIDE

Strength

EQ 1GM BASE/VIAL

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 065441

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of CEFEPIME 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.