Assyro AI

Orange Book product · Generic (ANDA)

DOXERCALCIFEROL

DOXERCALCIFEROL

Generic (ANDA)ANDA 205360TE ABRX AVET

At a glance

Sep 15, 2020

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 15, 2020

    5 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DOXERCALCIFEROL

Strength

0.5MCG

Dosage form

CAPSULE

Route

ORAL

TE code

AB

Application

ANDA 205360

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of DOXERCALCIFEROL

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.