Drug Master Files for: isosorbide mononitrate

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isosorbide mononitrate Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
1021	I	II	1/12/1967	NYSCO LABS INC	ISOSORBIDE DINITRATE TIMED RELEASE PELLETS
10823	I	II	3/18/1994	DOTTIKON EXCLUSIVE SYNTHESIS AG	ISOSORBIDE-5-NITRATE EXTENDED RELEASE PREMIXTURE 49.2%
12564	I	II	6/25/1997	SELOC AG	ISOSORBIDE CONCENTRATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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