Drug Master Files for: NABUMETONE

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NABUMETONE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11984	I	II	6/3/1996	ESTEVE QUIMICA SA	NABUMETONE
12091	I	II	8/13/1996	DINAMITE DIPHARMA SPA	NABUMETONE
12296	A	II	12/23/1996	CHEMI SPA	NABUMETONE
12445	I	II	3/18/1997	NAPP TECHNOLOGIES INC	NABUMETONE
12623	I	II	8/14/1997	PHARMACEUTICAL FINE CHEMICALS PFC BAHAMAS LTD	NABUMETONE
13105	I	II	7/30/1998	RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA	NABUMETONE
14174	I	II	6/4/1999	API INC	NABUMETONE DRUG SUBSTANCE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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