Drug Master Files for: BALSALAZIDE DISODIUM

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BALSALAZIDE DISODIUM Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12287	I	II	12/20/1996	SA AJINOMOTO OMNICHEM NV	BALSALAZIDE DISODIUM
12289	I	II	12/18/1996	COURTAULDS CHEMICALS	BALSALAZIDE DISODIUM
16256	I	II	1/2/2003	SA AJINOMOTO OMNICHEM NV	BALSALAZIDE DISODIUM
16425	A	II	2/17/2003	PHARMAZELL GMBH	BALSALAZIDE DISODIUM
17326	A	II	4/19/2004	FORMOSA LABORATORIES INC	BALSALAZIDE DISODIUM DIHYDRATE USP
17500	I	II	6/25/2004	FARCHEMIA SRL	BALSALAZIDE DISODIUM DIHYDRATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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