Drug Master Files for: vardenafil hydrochloride
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vardenafil hydrochloride Drug Master Files
| 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 |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
