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DEXTROSE 10% IN PLASTIC CONTAINER

ANDA

DEXTROSE | A209448 | FRESENIUS KABI USA LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: DEXTROSE 10% IN PLASTIC CONTAINER(TE code: AP)

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

1 letter from Drugs@FDA

Date	Submission	Document
Aug 16, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10GM/100ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jul 16, 2018

No patent or exclusivity listings for this strength.