Drug Master Files for: DYCLONINE HYDROCHLORIDE

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DYCLONINE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
19497	A	II	3/31/2006	CHEMPACIFIC CORP	DYCLONINE HYDROCHLORIDE DRUG SUBSTANCE
28587	A	II	2/18/2015	APAC PHARMACEUTICAL LLC	DYCLONINE HYDROCHLORIDE USP
3014	I		8/5/1977	BURDICK & JACKSON LABS,INC	DYCLONINE HYDROCHLORIDE
4032	I	II	12/23/1980	GANES CHEMICALS INC PENNSVILLE DIV	DYCLONINE HCL
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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