Drug Master Files for: tadalafil

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tadalafil Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
20640	A	II	6/15/2007	MYLAN LABORATORIES LTD	TADALAFIL USP
20884	A	II	9/26/2007	TEVA PHARMACEUTICAL INDUSTRIES LTD	TADALAFIL
20962	A	II	10/22/2007	ORCHID PHARMA LTD	TADALAFIL
21209	I	II	1/7/2008	DR REDDYS LABORATORIES LTD	TADALAFIL
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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