Drug Master Files for: ephedrine hydrochloride

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ephedrine hydrochloride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
1002	I		10/13/1966	NYSCO LABS INC	PSEUDOEPHEDRINE HCL TIMED RELEASE PELLETS
10320	A	II	6/24/1993	MALLADI DRUGS AND PHARMACEUTICALS LTD	D-PSEUDOEPHEDRINE HYDROCHLORIDE
10440	I	II	8/24/1993	WYCKOFF CHEMICAL CO INC	PSEUDOEPHEDRINE SULFATE
11665	I	II	9/15/1995	EURAND AMERICA INC	MICROCAPS PSEUDOEPHEDRINE HCL
11843	I	II	2/5/1996	EURAND INTERNATIONAL SPA	DIFFUCAPS PSEUDOEPHEDRINE HCL BULK PELLETS
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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