Drug Master Files for: Zambon Spa

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Zambon Spa Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
5080	I	II	7/4/1983	ZAMBON SPA	MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ALMISANO DI LONIGO (VICENZA).
5485	I	II	7/25/1984	ZAMBON SPA	IBUPROFEN USP XX
5788	I	II	3/29/1985	ZAMBON SPA	DOPAMINE HCL USP XX
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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