Drug Master Files for: Chemi Spa

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Chemi Spa Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11740	I	II	11/6/1995	CHEMI SPA	ETODOLAC
11834	A	II	1/29/1996	CHEMI SPA	BUPROPION HYDROCHLORIDE
11951	A	II	4/29/1996	CHEMI SPA	MESALAMINE USP
11952	I	II	5/2/1996	CHEMI SPA	5-ASA CRYSTALLIZED
12229	I	II	11/13/1996	CHEMI SPA	PENTAACETYLIOPAMIDOL INTERMEDIATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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