Assyro AI

Orange Book product · Generic (ANDA)

TADALAFIL

TADALAFIL

Generic (ANDA)ANDA 217606TE AB1RX FOURRTS LABS

At a glance

Aug 13, 2024

Approved

Generic (ANDA)

Application

AB1

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 13, 2024

    1 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

TADALAFIL

Strength

2.5MG

Dosage form

TABLET

Route

ORAL

TE code

AB1

Application

ANDA 217606

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of TADALAFIL

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.