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SODIUM FLUORIDE F 18

NDA

SODIUM FLUORIDE F-18 | N022494 | NATIONAL INSTITUTES HEALTH NATIONAL CANCER INSTITUTE DIV CANCER TREATMENT AND DIAGNOSIS

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
VANDA PHARMACEUTICALS INC. v. TEVA PHARMACEUTICALS USA, INC. 2:2022cv07528 1 patentANDA 216371tasimelteon	D.N.J.	2022-12-27	Terminated 2023-02-10	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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.

MERCK KGAASODIUM FLUORIDE

DMF 92801991

SUNLIT FLUO AND CHEMICAL CO LTDSODIUM FLUORIDE USP

DMF 119101996

MALLINCKRODT BAKER INCInactiveSODIUM FLUORIDE

DMF 82811989

HASHIMOTO CHEMICAL INDUSTRIES CO LTDInactiveSODIUM FLUORIDE

DMF 88271990

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 3, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: Jan 26, 2011

No patent or exclusivity listings for this strength.