Application 201171
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | TABLET;ORAL | EQ 25MG BASE | No | No |
| 002 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | TABLET;ORAL | EQ 50MG BASE | No | No |
| 003 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | TABLET;ORAL | EQ 100MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-1658 | Sildenafil | sildenafil | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1659 | Sildenafil | sildenafil | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1660 | Sildenafil | sildenafil | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 68788-7775 | Sildenafil | sildenafil | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7775 | Sildenafil | sildenafil | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7775 | Sildenafil | sildenafil | Preferred Pharmaceuticals, Inc. | ANDA | Current |