Drug Master Files for: PHENTOLAMINE MESYLATE

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PHENTOLAMINE MESYLATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11936	I	II	4/19/1996	SYNKEM DIV PLASTO SA	PHENTOLAMINE MESYLATE
12260	A	II	12/11/1996	RELIABLE BIOPHARMACEUTICAL LLC	PHENTOLAMINE MESYLATE, USP
16428	A	II	2/13/2003	INDUSTRIALE CHIMICA SRL	PHENTOLAMINE MESILATE USP
28193	A	II	6/16/2014	APICORE US LLC	PHENTOLAMINE MESYLATE, USP
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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