Drug Master Files for: galantamine hydrobromide

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galantamine hydrobromide Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14425	I	II	9/29/1999	JANSSEN PHARMACEUTICA NV	GALANTAMINE HYDROBROMIDE
15384	A	II	5/8/2001	JANSSEN PHARMACEUTICA NV	GALANTAMINE HYDROBROMIDE DRUG SUBSTANCE(SYNTHETIC)
17863	A	II	12/1/2004	SCINOPHARM TAIWAN LTD	GALANTAMINE HYDROBROMIDE USP
17967	I	II	1/3/2005	WUHAN SHIJI PHARMACEUTICAL CO LTD	GALANTAMINE HYDROBROMIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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