Drug Master Files for: TRIS PHARMA INC

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TRIS PHARMA INC Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
23870	A	II	7/20/2010	TRIS PHARMA INC	METHYLPHENIDATE ERL (METHYLPHENIDATE ER POWDER FOR ORAL SUSPENSION)
25909	A	II	4/18/2012	TRIS PHARMA INC	METHYLPHENIDATE ERCT (METHYLPHENIDATE HCI ER CHEWABLE TABLETS)
27314	A	II	7/26/2013	TRIS PHARMA INC	COD-CPM ER ORAL SUSPENSION
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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