Assyro AI

Orange Book product · Brand (NDA)

PLAVIX

CLOPIDOGREL BISULFATE

Brand (NDA)NDA 020839TE ABRX SANOFI AVENTIS US

At a glance

Nov 17, 1997

Approved

Brand (NDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 17, 1997

    29 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

CLOPIDOGREL BISULFATE

Strength

EQ 75MG BASE

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

NDA 020839

Product number

001

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.