Drug Master Files for: DEXMETHYLPHENIDATE HYDROCHLORIDE

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DEXMETHYLPHENIDATE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
13228	A	II	9/21/1998	SIEGFRIED USA LLC	DEXMETHYLPHENIDATE HYDROCHLORIDE
17117	A	II	1/23/2004	LONZA INC	DEXMETHYLPHENIDATE HYDROCHLORIDE (DMP.HCL)
20385	A	II	3/28/2007	EUTICALS INC	DEXMETHYLPHENIDATE HYDROCHLORIDE
29784	A	II	10/7/2015	AMPAC FINE CHEMICALS LLC	DEXMETHYLPHENIDATE HCl API
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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