Drug Master Files for: pemoline

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pemoline Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11780	A	II	12/24/1995	KATWIJK CHEMIE BV	PEMOLINE
12238	I	II	12/5/1996	HOECHST CELANESE CORP	PEMOLINE
12449	I	II	4/3/1997	PHARM ECO LABORATORIES INC	2-AMINO-5-PHENYL-4(5H)-OXAZOLONE-(PEMOLINE)
12796	I	II	12/15/1997	ORGAMOL SA	PEMOLINE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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