Drug Master Files for: amiloride hydrochloride

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amiloride hydrochloride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
4798	A	II	12/22/1982	OLON SPA	AMILORIDE HYDROCHLORIDE
5212	I	II	12/1/1983	SIEGFRIED AG	AMILORIDE HCL
7409	A	II	3/28/1988	CAMBREX PROFARMACO MILANO SRL	AMILORIDE HCL
7726	I	II	10/6/1988	SIMS	AMILORIDE HCL
8568	I	II	5/9/1990	EXXONMOBIL CHEMICAL CO	AMILORIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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