Assyro AI

Orange Book product · Generic (ANDA)

ERGOCALCIFEROL

ERGOCALCIFEROL

Generic (ANDA)ANDA 204276TE AARX PURACAP PHARM LLC

At a glance

Dec 07, 2018

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 07, 2018

    7 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ERGOCALCIFEROL

Strength

50,000 IU

Dosage form

CAPSULE

Route

ORAL

TE code

AA

Application

ANDA 204276

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ERGOCALCIFEROL

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.