Application 203962
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65862-689 | Sildenafil | Sildenafil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-689 | Sildenafil | Sildenafil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-689 | Sildenafil | Sildenafil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-690 | Sildenafil | Sildenafil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-690 | Sildenafil | Sildenafil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-690 | Sildenafil | Sildenafil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-691 | Sildenafil | Sildenafil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-691 | Sildenafil | Sildenafil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-691 | Sildenafil | Sildenafil | Aurobindo Pharma Limited | ANDA | Current |
| 68788-7218 | Sildenafil | Sildenafil | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 71205-220 | Sildenafil | Sildenafil | Proficient Rx LP | ANDA | Current |
| 71205-220 | Sildenafil | Sildenafil | Proficient Rx LP | ANDA | Current |