Drug Master Files for: docosanol

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docosanol Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
29410	A	II	6/19/2015	TEVA PHARMACEUTICAL INDUSTRIES LTD	DOCOSANOL
33064	A	II	9/7/2018	BIOPHORE INDIA PHARMACEUTICALS PVT LTD	DOCOSANOL
33229	A	II	10/17/2018	MAITHRI DRUGS PRIVATE LTD	DOCOSANOL
9513	A	II	1/17/1992	SASOL GERMANY GMBH	1-DOCOSANOL (BEHENYL ALCOHOL)
9514	I	II	1/17/1992	SASOL NORTH AMERICA INC	MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF 1-DOCOSANOL (BEHENYL ALCOHOL) IN BRUNSBUTTEL, GERMANY.
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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