Assyro AI

Orange Book product · Brand (NDA)

EMTRIVA

EMTRICITABINE

Brand (NDA)NDA 021500TE ABRX GILEAD
View EMTRICITABINE familyOpen on FDA Orange Book

At a glance

Jul 02, 2003

Approved

Brand (NDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 02, 2003

    23 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

EMTRICITABINE

Strength

200MG

Dosage form

CAPSULE

Route

ORAL

TE code

AB

Application

NDA 021500

Product number

001

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.

Book a Demo