Drug Master Files for: vardenafil hydrochloride

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vardenafil hydrochloride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
20780	A	II	8/17/2007	DR REDDYS LABORATORIES LTD	VARDENAFIL HYDROCHLORIDE TRIHYDRATE
25174	A	II	8/2/2011	ZAKLADY FARMACEUTYCZNE POLPHARMA SA	VARDENAFIL HYDROCHLORIDE TRIHYDRATE
25795	A	II	4/9/2012	MACLEODS PHARMACEUTICALS LTD	VARDENAFIL HYDROCHLORIDE TRIHYDRATE
28900	A	II	12/31/2014	ALEMBIC PHARMACEUTICALS LTD	VARDENAFIL HYDROCHLORIDE USP
30804	A	II	10/27/2016	RAKS PHARMA PVT LTD	VARDENAFIL HYDROCHLORIDE TRIHYDRATE USP
32908	A	II	9/20/2018	SMS PHARMACEUTICALS LTD	VARDENAFIL HYDROCHLORIDE TRIHYDRATE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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