Drug Master Files for: dronabinol

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dronabinol Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15082	A	II	10/6/2000	S AND B PHARMA INC DBA NORAC PHARMA	DRONABINOL
17629	I	II	8/27/2004	MALLINCKRODT INC	DRONABINOL IN SESAME OIL
18731	I	II	9/7/2005	RESOLUTION CHEMICALS LTD	DRONABINOL USP
19207	A	II	2/28/2006	INSYS MANUFACTURING LLC	DRONABINOL USP
19335	A	II	4/7/2006	RHODES TECHNOLOGIES	DRONABINOL, 10% IN SESAME OIL
20596	A	II	6/12/2007	AMRI RENSSELAER INC	DRONABINOL IN SESAME OIL DRUG SUBSTANCE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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