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SODIUM IODIDE I 123

NDA

SODIUM IODIDE I-123 | N018671 | CARDINAL HEALTH 418 INC

3 strengths0 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizens Petition from International Isotopes Inc FDA-2017-P-5592 · 7 docket documents International Isotopes Inc. filed this citizen petition under Section 505(i) requesting that the FDA amend the Orange Book to determine that Sodium Iodide I-123 Solution, 2 mCi/ml (NDA 017630, GE Healthcare) was not discontinued for safety or efficacy reasons and classify it as a Reference Listed Dr	505(q)	2017-09-12	Denied	International Isotopes Inc

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs2 inactive

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

BWXT MEDICAL LTDSODIUM IODIDE I-123

DMF 64401986

CURIUM US LLCSODIUM IODIDE I-123

DMF 353552020

MALLINCKRODT INC THE PHARMACEUTICALS BUSINESS OF COVIDIENInactiveSODIUM IODIDE I-123

DMF 80641989

INTERNATIONAL ISOTOPES INCInactiveSODIUM IODIDE I-123 RADIOCHEMICAL

DMF 150112000

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 17, 2008	SUPPL -16	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 100uCi

RLDAA

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: May 27, 1982

No patent or exclusivity listings for this strength.

#002 — 200uCi

RLDAA

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: May 27, 1982

#003 — 400uCi

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: May 27, 1982