Viewing data from:

MANGANESE SULFATE

NDA

MANGANESE SULFATE | N019228 | ABRAXIS PHARMACEUTICAL PRODUCTS

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Fresenius Kabi USA, LLC FDA-2020-P-2048 · 6 docket documents Fresenius Kabi USA, LLC filed this citizen petition on October 4, 2020, requesting that the FDA determine whether Abraxis Pharmaceutical Products withdrew Manganese Sulfate Eq 0.1mg manganese/mL (NDA 019228) for reasons of safety or efficacy, as required under 21 CFR 314.161 before an ANDA referenci	505(q)	2020-10-05	Granted	Fresenius Kabi USA, LLC

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

Clinical Trials

11 trials from ClinicalTrials.gov, 1 active, 7 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Safety Study of BMX-001 (Radio-protector) in Patients With Newly Diagnosed Anal Cancer NCT03386500	Phase 1/2	Active	University of Nebraska	24	2017-11-28 → 2029-12
Myo-inositol Versus D-chiro-inositol in the Treatment of Polycystic Ovary Syndrome and Insulin Resistance: Evaluation of Clinical, Metabolic, Endocrine and Ultrasound Parameters NCT01514942	Phase 4	Completed	AGUNCO Obstetrics and Gynecology Centre	—	—
Clinical Trial of Manganese-Enhanced MRI (MEMRI) to Assess Peri-Infarct Injury NCT02933034	Phase 1/2	Completed	Stanford University	33	2015-04 → 2019-02-03
Exploratory Study to Determine Tissue Alterations of Advanced Hepatocellular Carcinoma Induced by Electromagnetic Waves of Low Energy Amplitude Modulated to Specific Frequencies During Imaging Study by MRI NCT02692365	N/A	Completed	Hospital Sirio-Libanes	20	2015-09 → 2016-06
A Study of the Pan-immunotherapy in Patients With Relapsed/Refractory Ovarian Cancer NCT03989336	Phase 2	Completed	Chinese PLA General Hospital	84	2020-12-23 → 2023-12-10
Efficacy of EVP 1001-1 (SeeMore) in the Assessment of Myocardial Viability in Patients With Cardiovascular Disease NCT01989195	Phase 1/2	Completed	Stanford University	6	2013-05 → 2013-06
Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001 NCT02655601	Phase 1/2	Completed	BioMimetix JV, LLC	177	2018-09-25 → 2024-12-31
ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients NCT03689712	Phase 3	Completed	Galera Therapeutics, Inc.	455	2018-10-03 → 2023-08-25
A Safety Study of the Pan-immunotherapy in Patients With Unresectable/Metastatic Solid Tumors or Lymphomas NCT03991559	Phase 1	UNKNOWN	Chinese PLA General Hospital	20	2018-11-01 → 2020-05-31
An Open-label, Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic Pancreatic Cancer NCT03989310	Phase 1/2	UNKNOWN	Chinese PLA General Hospital	50	2019-03-01 → 2022-03-31

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

API Supply Chain9 active DMFs

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

JOST CHEMICAL COMANGANESE SULFATE MONOHYDRATE

DMF 305122016

METROCHEM API PRIVATE LTDMANGANESE SULFATE MONOHYDRATE USP

DMF 369602022

BIOPHORE INDIA PHARMACEUTICALS PVT LTDMANGANESE SULFATE MONOHYDRATE

DMF 373222022

HARMAN FINOCHEM LTDMANGANESE SULFATE USP

DMF 374852022

GLOBAL CALCIUM PRIVATE LTDMANGANESE SULFATE USP

DMF 376492022

GLAND PHARMA LTDMANGANESE SULFATE

DMF 378782022

ASCENSUS SPECIALTIES LLCMANGANESE SULFATE USP

DMF 384302023

MAITHRI DRUGS PRIVATE LTDMANGANESE SULFATE MONOHYDRATE USP

DMF 397712024

MUBY CHEM PRIVATE LTDMANGANESE SULFATE MONOHYDRATE USP

DMF 411332025

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

Products (1)

#001 — EQ 0.1MG MANGANESE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: May 5, 1987

No patent or exclusivity listings for this strength.