Drug Master Files for: quinidine gluconate

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quinidine gluconate Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12334	I	II	1/24/1997	PT SINKONA INDONESIA LESTARI	QUINIDINE GLUCONATE
2083	I	II	3/8/1973	GYMA LABORATORIES AMERICA INC	HYDROQUINIDINE ALGINATE
2723	I	II	8/5/1976	SOCIETE CHIMIQUE POINTET GIRARD SA	QUINIDINE GLUCONATE
2759	I	II	8/10/1976	BUCHLER AND CO	QUINIDINE SULFATE AND QUINIDINE PRODUCTS
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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