Assyro AI

FDA Orange Book · active-ingredient family

Indium in-111 pentetreotide kit

Indium in-111 pentetreotide kit is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:OCTREOSCAN · NDA 020314

1

Brand (NDA)

1

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable

ProductApplicantApplicationTEApproved
OCTREOSCANRLDCURIUMNDA 020314Jun 02, 1994

Generic (ANDA) products (1)

ProductApplicantApplicationTEApproved
INDIUM IN-111 PENTETREOTIDE KITSUN PHARM INDS INCANDA 212785Jul 01, 2024

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.

Indium in-111 pentetreotide kit — 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.