Drug Master Files for: fosinopril sodium

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fosinopril sodium Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15326	A	II	2/28/2001	AMINO CHEMICALS LTD	FOSINOPRIL SODIUM
15934	I	II	4/11/2002	QUIMICA SINTETICA SA	FOSINOPRIL SODIUM
16008	A	II	6/11/2002	HETERO DRUGS LTD	FOSINOPRIL SODIUM
16321	I	II	12/17/2002	SUN PHARMACEUTICAL INDUSTRIES LTD	FOSINOPRIL SODIUM USP (NON-STERILE BULK)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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