Drug Master Files for: ISRADIPINE

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ISRADIPINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
16369	A	II	1/21/2003	SOLARA A PHARMA SCIENCES LTD	ISRADIPINE, USP
17367	A	II	5/5/2004	CHEMO IBERICA SA	ISRADIPINE
17384	A	II	5/17/2004	YANGZHOU PHARMACEUTICAL CO LTD	ISRADIPINE (USP26)
17873	I	II	12/7/2004	SUN PHARMACEUTICAL INDUSTRIES LTD	ISRADIPINE UPS
19376	A	II	4/19/2006	CHEMOSWED AB	ISRADIPINE
20749	I	II	8/2/2007	CHEMWERTH INC	ISRADIPINE USP, NON-STERILE BULK DRUG SUBSTANCE
21013	I	II	10/29/2007	SAI ADVANTIUM PHARMA LTD	Isradipine 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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