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DEXTROSE 30% IN PLASTIC CONTAINER

NDA

DEXTROSE | N019345 | OTSUKA ICU MEDICAL LLC

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 Chain8 active DMFs2 inactive

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

ROQUETTE FRERESDEXTROSE MONOHYDRATE USP GRADE (LYCADEX® PF)

DMF 46971982

ROQUETTE AMERICA INCDEXTROSE MONOHYDRATE, USP GRADE

DMF 110591994

WEIFANG SHENGTAI MEDICINE CO LTDDEXTROSE MONOHYDRATE

DMF 300792015

WEIFANG SHENGTAI MEDICINE CO LTDDEXTROSE ANHYDROUS

DMF 300872015

TEREOS STARCH AND SWEETENERS IBERIA SAUDEXTROSE MONOHYDRATE (MERIDEX, MERIDEX PF)

DMF 332052018

SHANDONG TIANLI PHARMACEUTICAL CO LTDDEXTROSE ANHYDROUS

DMF 357372021

SHANDONG TIANLI PHARMACEUTICAL CO LTDDEXTROSE MONOHYDRATE

DMF 376182023

CSPC SHENGXUE GLUCOSE CO LTDDEXTROSE ANHYDROUS

DMF 412592025

XIWANG PHARMACEUTICAL CO LTDInactiveDEXTROSE MONOHYDRATE

DMF 264492012

XIWANG PHARMACEUTICAL CO LTDInactiveDEXTROSE ANHYDROUS

DMF 264502012

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
May 16, 2018	SUPPL -47	View Letter (PDF)
Feb 24, 2016	SUPPL -44	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 30GM/100ML

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jan 26, 1985

No patent or exclusivity listings for this strength.