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FDA Orange Book · active-ingredient family

Gallium dotatate ga-68

Gallium dotatate ga-68 is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:NETSPOT · NDA 208547

1

Brand (NDA)

0

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · powder

ProductApplicantApplicationTEApproved
NETSPOTRLDAAA USA INCNDA 208547Jun 01, 2016

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9375498Aug 10, 2032in 6 yr 3 mo
Product

Gallium dotatate ga-68 — 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.