Viewing data from:

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

No FDA citizen petitions matched from Regulations.gov

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