Drug Master Files for: PHENOBARBITAL SODIUM

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PHENOBARBITAL SODIUM Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
1003	I	II	10/19/1966	NYSCO LABS INC	PHENOBARBITAL TIMED RELEASE PELLETS
1049	A	II	3/21/1967	SIEGFRIED USA LLC	PHENOBARBITAL SODIUM USP
1171	I	II	4/17/1968	GANES CHEMICALS INC PENNSVILLE DIV	G. PACKAGING AND ANALYSIS OF SODIUM PHENOBARBITAL
1322	I		2/12/1969	VICTOR M HERMELIN CO DIV K-V PHARMACAL CO	DILAC 30MG /PHENOBARBITAL 45MG SUSTAINED RELEASE CAPSULES
1417	I		9/3/1969	VICTOR M HERMELIN CO DIV K-V PHARMACAL CO	DUROTATE PB (PETN 30MG AND PHENOBARBITAL 45MG) SUSTAINED RELEASE CAPS
1603	I	II	10/30/1970	GANES CHEMICALS INC PENNSVILLE DIV	N,N-DIMETHOXYMETHYLPHENOBARBITAL
16148	I	II	9/26/2002	AMRI RENSSELAER INC	PHENOBARBITAL SODIUM 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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