Drug Master Files for: SILDENAFIL CITRATE
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SILDENAFIL CITRATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 17778 | A | II | 10/25/2004 | TEVA PHARMACEUTICAL INDUSTRIES LTD | SILDENAFIL CITRATE |
| 19097 | A | II | 1/10/2006 | MYLAN LABORATORIES LTD | SILDENAFIL CITRATE USP |
| 21154 | A | II | 12/13/2007 | CADILA PHARMACEUTICALS LTD | SILDENAFIL CITRATE USP |
| 21250 | I | II | 1/22/2008 | SMS PHARMACEUTICALS LTD | Sildenafil Citrate |
| 21619 | A | II | 5/15/2008 | HETERO DRUGS LTD | SILDENAFIL CITRATE |
| 22037 | A | II | 9/25/2008 | DR REDDYS LABORATORIES LTD | SILDENAFIL CITRATE |
| 22142 | A | II | 10/31/2008 | TORRENT PHARMACEUTICALS LTD | SILDENAFIL CITRATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
