Drug Master Files for: TOLCAPONE

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TOLCAPONE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
24989	A	II	5/26/2011	PIRAMAL ENTERPRISES LTD	TOLCAPONE
25857	A	II	6/13/2012	PAR PHARMACEUTICAL INC	TOLCAPONE, USP
28308	A	II	6/17/2014	TOPCHEM PHARMACEUTICALS LTD	TOLCAPONE
28734	A	II	10/6/2014	RA CHEM PHARMA LTD	TOLCAPONE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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