Drug Master Files for: DIMENHYDRINATE

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DIMENHYDRINATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
2898	I	II	4/14/1977	GANES CHEMICALS INC PENNSVILLE DIV	DIMENHYDRINATE, BULK POWDER FORM
31353	A	II	2/6/2017	SHANGHAI WONDER PHARMACEUTICAL CO LTD	DIMENHYDRINATE
3159	I	II	1/31/1978	INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPA	DIPHENHYDRAMINE HCL & DIMENHYDRINATE
4615	I	II	7/22/1982	KNOLL AG LUDWIGSHAFEN	DIMENHYDRINATE
4627	A	II	7/13/1982	RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA	DIMENHYDRINATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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