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HICON

NDA

SODIUM IODIDE I-131 | N021305 | JUBILANT DRAXIMAGE INC DBA JUBILANT RADIOPHARMA

6 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 (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Ethicon, Inc. - Citizen Petition FDA-1976-C-0129 Ethicon Inc. filed this citizen petition on July 14, 1976, requesting FDA approval of a color additive petition amendment for the permanent listing of D&C Green No. 5 dye for use in nonabsorbable surgical suture made of nylon type 6 for general surgery applications. The petition includes an environm	Other	2012-08-09	Open	—

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF2 inactive

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

UNIV MISSOURI RESEARCH REACTOR CENTERSODIUM IODIDE I-131 SOLUTION

DMF 328542018

NORDION CANADA INCInactiveSODIUM IODIDE I-131

DMF 63721986

MDS NORDIONInactiveSODIUM IODIDE I-131

DMF 92291991

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

Approval Letters

13 letters from Drugs@FDA

Date	Submission	Document
Jun 15, 2021	SUPPL -47	View Letter (PDF)
Jul 12, 2016	SUPPL -42	View Letter (PDF)
Jun 21, 2016	SUPPL -41	View Letter (PDF)
Oct 5, 2011	SUPPL -27	View Letter (PDF)
Sep 28, 2011	SUPPL -25	View Letter (PDF)
Mar 4, 2008	SUPPL -16	View Letter (PDF)
Apr 25, 2007	SUPPL -11	View Letter (PDF)
Oct 26, 2006	SUPPL -10	View Letter (PDF)
Jan 20, 2006	SUPPL -5	View Letter (PDF)
May 20, 2005	SUPPL -3	View Letter (PDF)
Dec 2, 2004	SUPPL -2	View Letter (PDF)
Aug 15, 2003	SUPPL -1	View Letter (PDF)
Jan 24, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

Sort:

#002 — 1-250mCi/0.25ML

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Jan 24, 2003

No patent or exclusivity listings for this strength.

#003 — 1-500mCi/0.5ML

0 patents0 exclusivities▾

SOLUTION;ORAL | Approved: Jan 24, 2003

#005 — 1-1000mCi/ML

0 patents0 exclusivities▾

SOLUTION;ORAL | Approved: Apr 4, 2006

#007 — 250-1000mCi

RLDAA

0 patents0 exclusivities▾

SOLUTION;ORAL | Approved: Dec 5, 2011

#004 — 2-200mCi

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Nov 18, 2004

#006 — 0.009-0.1mCi

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: May 19, 2005