Drug Master Files for: nisoldipine

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nisoldipine Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10167	A	II	3/31/1993	BAYER AG	NISOLDIPINE
14337	A	II	7/28/1999	LUSOCHIMICA SPA	NISOLDIPINE
16215	A	II	10/22/2002	ERREGIERRE SPA	NISOLDIPINE
19329	I	II	4/4/2006	SANMAR SPECIALITY CHEMICALS LTD	NISOLDIPINE, NON-STERILE BULK DRUG SUBSTANCE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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