Drug Master Files for: DROSPIRENONE

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DROSPIRENONE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12138	A	II	9/9/1996	BAYER AG	DROSPIRENONE
17866	A	II	12/3/2004	GEDEON RICHTER PLC	DROSPIRENONE USP
19461	I	II	5/23/2006	3M DRUG DELIVERY SYSTEMS DIV	DROSPIRENONE/ETHINYL ESTRADIOL TRANSDERMAL DELIVERY SYSTEM
20676	A	II	7/11/2007	INDUSTRIALE CHIMICA SRL	DROSPIRENONE USP
21733	A	II	6/27/2008	STERLING SPA	DROSPIRENONE
22802	A	II	5/15/2009	NEWCHEM SPA	DROSPIRENONE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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