Assyro AI

Orange Book product · Generic (ANDA)

EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE

EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Generic (ANDA)ANDA 214053DISCN APOTEX

At a glance

May 17, 2024

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 17, 2024

    2 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Strength

120MG;EQ 15MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 214053

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

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.