Assyro AI

Orange Book product · Generic (ANDA)

ERTAPENEM SODIUM

ERTAPENEM SODIUM

Generic (ANDA)ANDA 209145DISCN SUN PHARM

At a glance

May 02, 2023

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 02, 2023

    3 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ERTAPENEM SODIUM

Strength

EQ 1GM BASE/VIAL

Dosage form

INJECTABLE

Route

INTRAMUSCULAR, INTRAVENOUS

TE code

Not listed

Application

ANDA 209145

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ERTAPENEM SODIUM

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.