Assyro AI

Orange Book product · Generic (ANDA)

MEROPENEM

MEROPENEM

Generic (ANDA)ANDA 091404TE APRX ACS DOBFAR

At a glance

Oct 26, 2011

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 26, 2011

    14 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

MEROPENEM

Strength

1GM/VIAL

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 091404

Product number

002

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of MEROPENEM

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.