Drug Master Files for: telmisartan

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telmisartan Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
18759	I	II	9/12/2005	GLENMARK PHARMACEUTICALS LTD	TELMISARTAN
19759	I	II	9/11/2006	DR REDDYS LABORATORIES LTD	TELMISARTAN
19987	A	II	11/22/2006	CIPLA LTD	TELMISARTAN USP
20109	A	II	1/3/2007	MYLAN LABORATORIES LTD	TELMISARTAN USP
20285	A	II	2/7/2007	ALEMBIC PHARMACEUTICALS LTD	TELMISARTAN 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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