Application 206069
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ARMODAFINIL | ARMODAFINIL | TABLET;ORAL | 50MG | No | No |
| 002 | ARMODAFINIL | ARMODAFINIL | TABLET;ORAL | 150MG | No | No |
| 003 | ARMODAFINIL | ARMODAFINIL | TABLET;ORAL | 250MG | No | No |
| 004 | ARMODAFINIL | ARMODAFINIL | TABLET;ORAL | 200MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65862-805 | Armodafinil | Armodafinil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-805 | Armodafinil | Armodafinil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-805 | Armodafinil | Armodafinil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-806 | Armodafinil | Armodafinil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-806 | Armodafinil | Armodafinil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-806 | Armodafinil | Armodafinil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-807 | Armodafinil | Armodafinil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-807 | Armodafinil | Armodafinil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-807 | Armodafinil | Armodafinil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-998 | Armodafinil | Armodafinil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-998 | Armodafinil | Armodafinil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-998 | Armodafinil | Armodafinil | Aurobindo Pharma Limited | ANDA | Current |
| 68788-7426 | Armodafinil | Armodafinil | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7593 | Armodafinil | Armodafinil | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7593 | Armodafinil | Armodafinil | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7593 | Armodafinil | Armodafinil | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7826 | Armodafinil | Armodafinil | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7826 | Armodafinil | Armodafinil | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7880 | Armodafinil | Armodafinil | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7880 | Armodafinil | Armodafinil | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 71335-1193 | Armodafinil | Armodafinil | Bryant Ranch Prepack | ANDA | Current |
| 71335-1193 | Armodafinil | Armodafinil | Bryant Ranch Prepack | ANDA | Current |
| 71335-1193 | Armodafinil | Armodafinil | Bryant Ranch Prepack | ANDA | Current |
| 71335-1193 | Armodafinil | Armodafinil | Bryant Ranch Prepack | ANDA | Current |
| 71335-1308 | Armodafinil | Armodafinil | Bryant Ranch Prepack | ANDA | Current |
| 71335-1308 | Armodafinil | Armodafinil | Bryant Ranch Prepack | ANDA | Current |
| 71335-1308 | Armodafinil | Armodafinil | Bryant Ranch Prepack | ANDA | Current |
| 72189-041 | ARMODAFINIL | ARMODAFINIL | Direct_Rx | ANDA | Current |
| 72189-133 | ARMODAFINIL | ARMODAFINIL | direct rx | ANDA | Current |
| 72189-133 | ARMODAFINIL | ARMODAFINIL | direct rx | ANDA | Current |