Drug Master Files for: DIATRIZOATE SODIUM

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DIATRIZOATE SODIUM Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
20924	A	II	10/5/2007	AMRI RENSSELAER INC	DIATRIZOATE SODIUM USP DRUG SUBSTANCE
27165	A	II	5/22/2013	AMRI RENSSELAER INC	DIATRIZOATE MEGLUMINE, USP
28739	A	II	11/5/2014	BIOPHORE INDIA PHARMACEUTICALS PVT LTD	DIATRIZOATE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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