Assyro AI

Orange Book product · Brand (NDA)

LEUCOVORIN CALCIUM

LEUCOVORIN CALCIUM

Brand (NDA)NDA 018459DISCN XANODYNE PHARM

At a glance

Jan 30, 1986

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 30, 1986

    41 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

LEUCOVORIN CALCIUM

Strength

EQ 5MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 018459

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

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.