Drug Master Files for: LOPERAMIDE HYDROCHLORIDE

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LOPERAMIDE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10028	A	II	12/30/1992	OLON SPA	LOPERAMIDE HYDROCHLORIDE
10517	A	II	9/30/1993	OLON SPA	LOPERAMIDE HYDROCHLORIDE
10942	I	II	6/17/1994	JANSSEN PHARMACEUTICA NV	LOPERAMIDE HYDROCHLORIDE
27731	A	II	12/6/2013	VASUDHA PHARMA CHEM LTD	LOPERAMIDE HYDROCHLORIDE USP
30201	A	II	4/28/2016	ADARE PHARMACEUTICALS INC	LOPERAMIDE MICROCAPS?
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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