Drug Master Files for: methylphenidate

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methylphenidate Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10137	A	II	3/5/1993	JOHNSON MATTHEY INC	METHYLPHENIDATE HYDROCHLORIDE USP
11635	I	II	8/31/1995	UCB INC	METHYLPHENIDATE HYDROCHLORIDE, USP
12769	A	II	11/25/1997	SPECGX LLC	METHYLPHENIDATE HYDROCHLORIDE USP
12989	I	II	5/15/1998	SIEGFRIED USA LLC	METHYLPHENIDATE HYDROCHLORIDE USP
13132	A	II	8/12/1998	SPECGX LLC	METHYLPHENIDATE BASE
13133	I	II	8/14/1998	ELAN DRUG DELIVERY INC	RITALIN QD (METHYLPHENIDATE) ONCE DAILY CAPSULES
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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