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Orange Book product · Generic (ANDA)

LEVOLEUCOVORIN CALCIUM

LEVOLEUCOVORIN CALCIUM

Generic (ANDA)ANDA 210892TE APRX GLAND

At a glance

Sep 14, 2018

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 14, 2018

    7 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

LEVOLEUCOVORIN CALCIUM

Strength

EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

AP

Application

ANDA 210892

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of LEVOLEUCOVORIN 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.