Assyro AI

Orange Book product · Brand (NDA)

EMTRIVA

EMTRICITABINE

Brand (NDA)NDA 021896RX GILEAD
View EMTRICITABINE familyOpen on FDA Orange Book

At a glance

Sep 28, 2005

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 28, 2005

    21 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

EMTRICITABINE

Strength

10MG/ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 021896

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

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