Drug Master Files for: fludrocortisone acetate

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fludrocortisone acetate Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14136	A	II	5/12/1999	FARMABIOS SPA	FLUDROCORTISONE ACETATE
14703	A	II	12/20/1999	TEVA PHARMACEUTICAL INDUSTRIES LTD	FLUDROCORTISONE ACETATE
21054	A	II	11/20/2007	CRYSTAL PHARMA SAU	FLUDROCORTISONE ACETATE USP
22994	A	II	7/27/2009	APICORE US LLC	FLUDROCORTISONE ACETATE USP
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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