Drug Master Files for: PROTAMINE SULFATE

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PROTAMINE SULFATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
1037	I	II	3/1/1967	HOFFMANN LA ROCHE INC	PROTAMINE HCL, RO 6-1588/1
14973	I	II	7/27/2000	BIOCHEM CORP	PROTAMINE SULFATE
15421	A	II	1/25/2000	YUKI GOSEI KOGYO CO LTD	PROTAMINE SULFATE
19008	I	II	12/2/2005	RELIABLE BIOPHARMACEUTICAL LLC	PROTAMINE SULFATE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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