Drug Master Files for: ARGININE HYDROCHLORIDE

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ARGININE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10131	I	II	4/7/1989	CORDEN PHARMA LATINA SPA	L-ARGININE
1274	I	II	12/31/1968	TANABE SEIYAKU CO LTD	L-ARGININE MONOHYDROCHLORIDE
18843	A	II	10/7/2005	ORCHID PHARMA LTD	ARGININE (STERILE BULK)
18923	A	II	10/31/2005	ORCHID PHARMA LTD	CEFEPIME & ARGININE (STERILE BULK)
1929	I	II	5/9/1972	TANABE SEIYAKU CO LTD	L-ARGININE BASE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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