Drug Master Files for: DIGOXIN

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DIGOXIN Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10067	I	II	1/31/1993	PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO	DIGOXIN DRUG SUBSTANCE
21559	A	II	4/15/2008	BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG	DIGOXIN 20 MICROMETER
2253	I	II	3/28/1974	RP SCHERER CORP	DIGOXIN CAPS
2277	I	II	5/17/1974	ROCHE DIAGNOSTICS GMBH	DIGOXIN PRODUCTS
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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