Drug Master Files for: CLONIDINE

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CLONIDINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12866	A	II	2/9/1998	SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRL	CLONIDINE BASE
12964	A	II	4/27/1998	PCAS	CLONIDINE BASE
16601	A	II	5/21/2003	PCAS	APRACLONIDINE HYDROCHLORIDE
16768	A	II	8/18/2003	FORMOSA LABORATORIES INC	APRACLONIDINE HYDROCHLORIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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