Drug Master Files for: GLYCOPYRROLATE

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GLYCOPYRROLATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
16972	A	II	11/13/2003	AMSA ANONIMA MATERIE SINTETICHE AND AFFINI SPA	GLYCOPYRROLATE
18106	A	II	2/22/2005	PCAS	GLYCOPYRROLATE
18727	A	II	8/31/2005	HIKMA PHARMACEUTICALS	GLYCOPYRROLATE USP
19026	A	II	12/10/2005	AKSHAT PHARMA PRIVATE LTD	GLYCOPYRROLATE USP
19710	A	II	8/28/2006	HARMAN FINOCHEM LTD	GLYCOPYRROLATE USP
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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