Application 206401
- Type
- ANDA
- Sponsor
- AJANTA PHARMA LTD
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 |
|---|---|---|---|---|---|
| 27241-067 | Sildenafil Citrate | Sildenafil | Ajanta Pharma Limited | ANDA | Current |
| 27241-067 | Sildenafil Citrate | Sildenafil | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-067 | Sildenafil Citrate | Sildenafil | Ajanta Pharma Limited | ANDA | Current |
| 27241-068 | Sildenafil Citrate | Sildenafil | Ajanta Pharma Limited | ANDA | Current |
| 27241-068 | Sildenafil Citrate | Sildenafil | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-068 | Sildenafil Citrate | Sildenafil | Ajanta Pharma Limited | ANDA | Current |
| 27241-069 | Sildenafil Citrate | Sildenafil | Ajanta Pharma Limited | ANDA | Current |
| 27241-069 | Sildenafil Citrate | Sildenafil | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-069 | Sildenafil Citrate | Sildenafil | Ajanta Pharma Limited | ANDA | Current |
| 50090-5906 | Sildenafil Citrate | Sildenafil | A-S Medication Solutions | ANDA | Current |
| 68788-8301 | Sildenafil Citrate | Sildenafil | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 71335-1437 | Sildenafil Citrate | Sildenafil | Bryant Ranch Prepack | ANDA | Current |
| 71335-1437 | Sildenafil Citrate | Sildenafil | Bryant Ranch Prepack | ANDA | Current |