Last Updated: November 8, 2026

Drug Master Files for: BENZTROPINE MESYLATE

BENZTROPINE MESYLATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
23719	A	II	6/4/2010	ARCH PHARMALABS LTD	BENZTROPINE MESYLATE USP
28840	A	II	12/3/2015	CEDARBURG PHARMACEUTICALS INC	BENZTROPINE MESYLATE
32136	A	II	2/9/2018	NAVINTA LLC	BENZTROPINE MESYLATE USP
33126	A	II	9/30/2018	HARMAN FINOCHEM LTD	BENZTROPINE MESYLATE USP
6189	I	II	1/30/1986	ORION CORP LTD	BENZTROPINE MESYLATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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