Drug Master Files for: BUTABARBITAL SODIUM

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BUTABARBITAL SODIUM Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
1048	I	II	3/24/1967	GANES CHEMICALS INC PENNSVILLE DIV	BUTABARBITAL
1217	I	II	8/2/1968	VICTOR M HERMELIN CO DIV K-V PHARMACAL CO	PENTRITOL-B (PETN 30MG & BUTABARBITAL 50MG TEMPULES)
14438	A	II	10/4/1999	CHATTEM CHEMICALS INC	BUTABARBITAL SODIUM
14636	A	II	12/18/1999	CEDARBURG PHARMACEUTICALS INC	BUTABARBITAL 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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