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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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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#001 — EQ 0.1MG MANGANESE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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