Assyro AI

Orange Book product · Brand (NDA)

REYATAZ

ATAZANAVIR SULFATE

Brand (NDA)NDA 021567TE ABRX BRISTOL MYERS SQUIBB

At a glance

Oct 16, 2006

Approved

Brand (NDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 16, 2006

    20 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

ATAZANAVIR SULFATE

Strength

EQ 300MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

AB

Application

NDA 021567

Product number

004

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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.