Drug Master Files for: INDOMETHACIN SODIUM

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INDOMETHACIN SODIUM Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
21740	A	II	6/28/2008	MACLEODS PHARMACEUTICALS LTD	INDOMETHACIN DRUG SUBSTANCE
21984	A	II	9/16/2008	CSPC OUYI PHARMACEUTICAL CO LTD	INDOMETHACIN
22751	A	II	4/29/2009	SOLARA A PHARMA SCIENCES LTD	INDOMETHACIN SODIUM
25401	A	II	10/31/2011	GLAND PHARMA LTD	INDOMETHACIN SODIUM USP
2633	I	II	3/1/1976	INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPA	INDOMETHACIN
26340	A	II	4/24/2013	IROKO PHARMACEUTICALS LLC	TIVORBEX (INDOMETHACIN) CAPSULES
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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