Drug Master Files for: DICLOFENAC

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DICLOFENAC Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10360	I	II	7/14/1993	IROTEC LABORATORIES	DICLOFENAC SODIUM
10831	A	II	3/24/1994	YUNG ZIP CHEMICAL IND CO LTD	DICLOFENAC POTASSIUM
11267	A	II	12/23/1994	OLON SPA	DICLOFENAC POTASSIUM
11499	I	II	5/11/1995	ASSIA CHEMICAL INDUSTRIES LTD	DICLOFENAC SODIUM
11676	I	II	9/26/1995	AMOLI ORGANICS LTD	DICLOFENAC SODIUM
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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