Drug Master Files for: PHENYLBUTAZONE

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PHENYLBUTAZONE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
1548	I	II	7/23/1970	AMSA ANONIMA MEDICINALI SINTETICI AND AFFINI SPA	PHENYLBUTAZONE
1702	I	II	12/17/1970	INQUIME INDS QUIMECA ESTENE SA	PHENYLBUTAZONE USP
1769	I		7/26/1971	AS SYNTHETICS	PHENYLBUTAZONE
1826	I		12/6/1971	ALLIED CHEM CORP	PHENYLBUTAZONE
1925	I	II	5/1/1972	RP SCHERER CORP	PHENYLBUTAZONE CAPSULES 100MG
2017	I		10/16/1972	ACETO CHEMICAL CO INC	PHENYLBUTAZONE (BULK)
2423	I	II	3/27/1975	NAPP CHEMICALS INC	PHENYLBUTAZONE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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