Last Updated: November 8, 2026

Drug Master Files for: HYDROXOCOBALAMIN

HYDROXOCOBALAMIN Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
16152	A	II	9/25/2002	SANOFI CHIMIE	HYDROXOCOBALAMIN ACETATE PH.EUR.,JP,PYROGEN-FREE
18216	A	II	3/30/2005	SANOFI CHIMIE	HYDROXOCOBALAMIN
27229	A	II	6/4/2013	HEBEI HUARONG PHARMACEUTICAL CO LTD	HYDROXOCOBALAMIN ACETATE
9100	I	II	5/6/1991	HOECHST MARION ROUSSEL SA	HYDROXOCOBALAMIN BASE
>DMF No.	>Status	>Type	>Submission Date	>Holder	>Subject

Drug Master File Glossary

STATUS OF DMFS

A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
I = Inactive
N = Not an assigned number
P = DMF Pending Filing Review

TYPES OF DMFs

Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Type III Packaging Material
Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V FDA Accepted Reference Information

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