Application 202566
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MODAFINIL | MODAFINIL | TABLET;ORAL | 100MG | No | No |
| 002 | MODAFINIL | MODAFINIL | TABLET;ORAL | 200MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50090-2472 | Modafinil | Modafinil | A-S Medication Solutions | ANDA | Current |
| 50090-2473 | Modafinil | Modafinil | A-S Medication Solutions | ANDA | Current |
| 50090-2473 | Modafinil | Modafinil | A-S Medication Solutions | ANDA | Current |
| 50268-570 | Modafinil | Modafinil | AvPAK | ANDA | Current |
| 50268-570 | Modafinil | Modafinil | AvPAK | ANDA | Current |
| 50268-570 | Modafinil | Modafinil | AvPAK | ANDA | Current |
| 50268-570 | Modafinil | Modafinil | AvPAK | ANDA | Current |
| 50268-571 | Modafinil | Modafinil | AvPAK | ANDA | Current |
| 50268-571 | Modafinil | Modafinil | AvPAK | ANDA | Current |
| 50268-571 | Modafinil | Modafinil | AvPAK | ANDA | Current |
| 50268-571 | Modafinil | Modafinil | AvPAK | ANDA | Current |
| 57237-154 | Modafinil | Modafinil | Rising Health, LLC | ANDA | Current |
| 57237-154 | Modafinil | Modafinil | Rising Health, LLC | ANDA | Current |
| 57237-154 | Modafinil | Modafinil | Rising Health, LLC | ANDA | Current |
| 57237-155 | Modafinil | Modafinil | Rising Health, LLC | ANDA | Current |
| 57237-155 | Modafinil | Modafinil | Rising Health, LLC | ANDA | Current |
| 57237-155 | Modafinil | Modafinil | Rising Health, LLC | ANDA | Current |
| 63629-4998 | Modafinil | Modafinil | Bryant Ranch Prepack | ANDA | Current |
| 63629-4998 | Modafinil | Modafinil | Bryant Ranch Prepack | ANDA | Current |
| 63629-7315 | Modafinil | Modafinil | Bryant Ranch Prepack | ANDA | Current |
| 63629-7315 | Modafinil | Modafinil | Bryant Ranch Prepack | ANDA | Current |
| 63629-7315 | Modafinil | Modafinil | Bryant Ranch Prepack | ANDA | Current |
| 65862-601 | Modafinil | Modafinil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-601 | Modafinil | Modafinil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-601 | Modafinil | Modafinil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-601 | Modafinil | Modafinil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-601 | Modafinil | Modafinil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-602 | Modafinil | Modafinil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-602 | Modafinil | Modafinil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-602 | Modafinil | Modafinil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-602 | Modafinil | Modafinil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-602 | Modafinil | Modafinil | Aurobindo Pharma Limited | ANDA | Current |
| 68071-5121 | Modafinil | Modafinil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5121 | Modafinil | Modafinil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68084-621 | Modafinil | Modafinil | American Health Packaging | ANDA | Current |
| 68084-621 | Modafinil | Modafinil | American Health Packaging | ANDA | Current |
| 68084-621 | Modafinil | Modafinil | American Health Packaging | ANDA | Current |
| 68084-621 | Modafinil | Modafinil | American Health Packaging | ANDA | Current |
| 68084-721 | Modafinil | Modafinil | American Health Packaging | ANDA | Current |
| 68084-721 | Modafinil | Modafinil | American Health Packaging | ANDA | Current |
| 68084-721 | Modafinil | Modafinil | American Health Packaging | ANDA | Current |
| 68084-721 | Modafinil | Modafinil | American Health Packaging | ANDA | Current |
| 68788-7432 | Modafinil | Modafinil | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7432 | Modafinil | Modafinil | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7432 | Modafinil | Modafinil | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7432 | Modafinil | Modafinil | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 71205-477 | Modafinil | Modafinil | Proficient Rx LP | ANDA | Current |
| 71205-544 | Modafinil | Modafinil | Proficient Rx LP | ANDA | Current |
| 71335-1122 | Modafinil | Modafinil | Bryant Ranch Prepack | ANDA | Current |
| 71335-1122 | Modafinil | Modafinil | Bryant Ranch Prepack | ANDA | Current |
| 71335-1122 | Modafinil | Modafinil | Bryant Ranch Prepack | ANDA | Current |
| 71335-1173 | Modafinil | Modafinil | Bryant Ranch Prepack | ANDA | Current |
| 71335-1173 | Modafinil | Modafinil | Bryant Ranch Prepack | ANDA | Current |
| 71335-1173 | Modafinil | Modafinil | Bryant Ranch Prepack | ANDA | Current |