Drug Master Files for: ATROPINE SULFATE

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ATROPINE SULFATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12067	I	II	7/23/1996	BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG	HOMATROPINE HYDROBROMIDE
23963	A	II	7/12/2010	SAURAV CHEMICALS LTD	HOMATROPINE METHYLBROMIDE USP
28423	A	II	7/8/2014	CEDARBURG PHARMACEUTICALS INC	ATROPINE SULFATE, USP
28530	A	II	7/28/2014	HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTD	HOMATROPINE METHYLBROMIDE
28978	A	II	12/25/2014	HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTD	ATROPINE SULFATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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