Drug Master Files for: CARMUSTINE

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CARMUSTINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10290	A	II	6/14/1993	JOHNSON MATTHEY PHARMACEUTICAL MATERIALS	CARMUSTINE
13169	A	II	9/1/1998	AMPAC FINE CHEMICALS LLC	CARMUSTINE (BCNU)
2038	I	II	1/10/1973	BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO	CARMUSTINE (BCNU) BULK & CARMUSTINE (BCNU) FOR INJ
22637	A	II	3/20/2009	CHEMPACIFIC CORP	CARMUSTINE DRUG SUBSTANCE
22905	A	II	6/22/2009	EMCURE PHARMACEUTICALS LTD	CARMUSTINE USP
30184	A	II	3/24/2017	AGNO PHARMA	CARMUSTINE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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