Assyro AI

Orange Book product · Brand (NDA)

LOVENOX

ENOXAPARIN SODIUM

Brand (NDA)NDA 020164TE ABRX SANOFI AVENTIS US

At a glance

Jan 23, 2003

Approved

Brand (NDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 23, 2003

    23 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ENOXAPARIN SODIUM

Strength

300MG/3ML (100MG/ML)

Dosage form

INJECTABLE

Route

INTRAVENOUS, SUBCUTANEOUS

TE code

AB

Application

NDA 020164

Product number

009

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

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.