Drug Master Files for: ethacrynate sodium

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ethacrynate sodium Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
26338	A	II	3/1/2013	CHEMWERTH INC	ETHACRYNATE SODIUM NON-STERILE, BULK DRUG
30813	A	II	9/19/2016	BIOPHORE INDIA PHARMACEUTICALS PVT LTD	ETHACRYNATE SODIUM
31600	A	II	4/26/2017	SAI LIFE SCIENCES LTD	ETHACRYNATE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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