Drug Master Files for: INGENOL MEBUTATE

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INGENOL MEBUTATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
28747	A	II	12/22/2014	INDENA SPA	INGENOL MEBUTATE
29556	A	II	7/17/2015	SICHUAN XIELI PHARMACEUTICAL CO LTD	INGENOL MEBUTATE
30117	I	II	12/31/2015	DR REDDYS LABORATORIES LTD	INGENOL MEBUTATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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