Assyro AI

Orange Book product · Generic (ANDA)

CEFEPIME HYDROCHLORIDE

CEFEPIME HYDROCHLORIDE

Generic (ANDA)ANDA 212721DISCN ASTRAL

At a glance

Jul 21, 2020

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 21, 2020

    6 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

CEFEPIME HYDROCHLORIDE

Strength

EQ 1GM BASE/VIAL

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 212721

Product number

001

Marketing status

DISCN

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.