Assyro AI

FDA Orange Book · active-ingredient family

Lactitol

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

Reference-listed drug:PIZENSY · NDA 211281

1

Brand (NDA)

0

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · for solution

ProductApplicantApplicationTEApproved
PIZENSYRLDBRAINTREE LABSNDA 211281—Feb 12, 2020

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10806743May 12, 2037in 11 yr 1 mo
U-1516

Lactitol — frequently asked questions

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

Agent CTA Background

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