Drug Master Files for: dexmedetomidine hydrochloride

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dexmedetomidine hydrochloride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
13810	A	II	10/30/1998	FERMION OY	DEXMEDETOMIDINE HYDROCHLORIDE
22681	A	II	3/31/2009	ALCAMI WISCONSIN CORP	DEXMEDETOMIDINE HYDROCHLORIDE USP (FP-071)
23132	A	II	9/28/2009	RELIABLE BIOPHARMACEUTICAL LLC	DEXMEDETOMIDINE HCI
23232	A	II	10/30/2009	GLAND PHARMA LTD	DEXMEDETOMIDINE HYDROCHLORIDE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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