Drug Master Files for: ALBENDAZOLE

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ALBENDAZOLE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12308	I	II	1/10/1997	CHANGZOU SYNTHETIC MATERIAL PLANT	ALBENDAZOLE
17754	A	II	11/8/2004	UNIMARK REMEDIES LTD	ALBENDAZOLE USP
25914	A	II	3/27/2012	UQUIFA MEXICO SA DE CV	ALBENDAZOLE
28558	A	II	8/13/2014	SOLARA A PHARMA SCIENCES LTD	ALBENDAZOLE
29493	A	II	6/30/2015	CIPLA LTD	ALBENDAZOLE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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