Drug Master Files for: MIDODRINE HYDROCHLORIDE

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MIDODRINE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15610	I	II	9/4/2001	CADILA HEALTHCARE LTD	MIDODRINE HYDROCHLORIDE
16006	A	II	6/13/2002	INDUSTRIALE CHIMICA SRL	MIDODRINE HYDROCHLORIDE
16017	A	II	6/21/2002	EDMOND PHARMA SRL	MIDODRINE HYDROCHLORIDE
16135	A	II	9/16/2002	TEVA PHARMACEUTICAL INDUSTRIES LTD	MIDODRINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE
16417	I	II	2/6/2003	CHEMAGIS LTD	MIDODRINE HYDROCHLORIDE
16481	A	II	3/24/2003	ALCAMI WISCONSIN CORP	MIDODRINE HYDROCHLORIDE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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