Application 209057
- Type
- ANDA
- Sponsor
- CROSSMEDIKA SA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | TABLET;ORAL | 2.5MG | No | No |
| 002 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 003 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 004 | VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | TABLET;ORAL | 20MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0527-2800 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-2800 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-2800 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-2800 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-2801 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-2801 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-2801 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-2801 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-2802 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-2802 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-2802 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-2802 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-2803 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-2803 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-2803 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-2803 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 42291-847 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-847 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | AvKARE | ANDA | Current |
| 42291-847 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | AvKARE | ANDA | Current |
| 42291-848 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-848 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | AvKARE | ANDA | Current |
| 42291-848 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | AvKARE | ANDA | Current |
| 71610-310 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-508 | Vardenafil Hydrochloride | Vardenafil Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |