Orange Book product · Brand (NDA)

KHAPZORY

LEVOLEUCOVORIN

Brand (NDA)NDA 211226RX ACROTECH BIOPHARMA

Oct 19, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 19, 2018
7 yr 9 mo ago
Today
Patent 11541012 expires
Listed drug product patent expiration.
Mar 25, 2039
in 12 yr 11 mo

Active ingredient

LEVOLEUCOVORIN

Strength

175MG/VIAL

Dosage form

POWDER

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 211226

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11541012	Mar 25, 2039	in 12 yr 11 mo	Product