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INDIUM IN 111 CHLORIDE

NDA

INDIUM IN-111 CHLORIDE | N019841 | CURIUM US LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CURIUM US LLCINDIUM IN-111 CHLORIDE STERILE SOLUTION

DMF 99191992

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 16, 2004	SUPPL -3	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5mCi/0.5ML

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Sep 27, 1994

No patent or exclusivity listings for this strength.