Drug Master Files for: AVANAFIL

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AVANAFIL Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
24849	A	II	5/19/2011	VIVUS INC	AVANAFIL
28095	A	II	3/27/2014	MSN LABORATORIES PRIVATE LTD	AVANAFIL [ROUTE CODE AV]
28732	A	II	10/7/2014	SANOFI CHIMIE	AVANAFIL
29689	A	II	8/20/2015	ZAKLADY FARMACEUTYCZNE POLPHARMA SA	AVANAFIL
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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