Assyro AI

Orange Book product · Generic (ANDA)

LEUCOVORIN CALCIUM PRESERVATIVE FREE

LEUCOVORIN CALCIUM

Generic (ANDA)ANDA 040147DISCN HOSPIRA

At a glance

Jun 25, 1997

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 25, 1997

    29 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

LEUCOVORIN CALCIUM

Strength

EQ 100MG BASE/10ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

SOLUTION

Route

INTRAMUSCULAR, INTRAVENOUS

TE code

Not listed

Application

ANDA 040147

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of LEUCOVORIN CALCIUM

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.