Assyro AI

Orange Book product · Generic (ANDA)

ALCAFTADINE

ALCAFTADINE

Generic (ANDA)ANDA 209706OTC GLAND

At a glance

Mar 01, 2024

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 01, 2024

    2 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ALCAFTADINE

Strength

0.25%

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

ANDA 209706

Product number

001

Marketing status

OTC

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ALCAFTADINE

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.