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FDA Orange Book · active-ingredient family

Levoleucovorin

Levoleucovorin is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:KHAPZORY · NDA 211226

1

Brand (NDA)

0

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · powder

ProductApplicantApplicationTEApproved
KHAPZORYRLD×2ACROTECH BIOPHARMANDA 211226Oct 19, 2018

Listed patents (1)

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

Levoleucovorin — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.