Drug Master Files for: olsalazine sodium

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olsalazine sodium Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
17677	A	II	9/13/2004	DOTTIKON EXCLUSIVE SYNTHESIS AG	OLSALAZINE SODIUM
21633	I	II	5/19/2008	EMCURE PHARMACEUTICALS LTD	OLSALAZINE SODIUM
21981	A	II	9/8/2008	CORDEN PHARMA BERGAMO SPA	OLSALAZINE SODIUM
27618	A	II	12/27/2013	EMCURE PHARMACEUTICALS LTD	OLSALAZINE SODIUM (PROCESS II)
6443	I	II	6/23/1986	PHARMACIA AND UPJOHN	OLSALAZINE SODIUM
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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