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SODIUM THIOSULFATE

NDA

SODIUM THIOSULFATE | N020166 | UNITED STATES ARMY OFFICE SURGEON GENERAL

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

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies NCT04847063	Phase 1	Recruiting	National Cancer Institute (NCI)	60	2021-10-19 → 2034-12-30

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain3 active DMFs1 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

BIOPHORE INDIA PHARMACEUTICALS PVT LTDSODIUM THIOSULFATE

DMF 355132020

CIPLA LTDSODIUM THIOSULFATE USP

DMF 362452021

INTAS PHARMACEUTICALS LTDSODIUM THIOSULFATE

DMF 367822022

LUITPOLD PHARMACEUTICALS INCInactiveSODIUM THIOSULFATE INJECTION, USP 25% ML VIAL

DMF 207152007

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

Products (1)

#001 — 250MG/ML

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Feb 14, 1992

No patent or exclusivity listings for this strength.