Application 207466
- Type
- ANDA
- Sponsor
- SCIEGEN PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | METAXALONE | METAXALONE | TABLET;ORAL | 800MG | No | No |
| 002 | METAXALONE | METAXALONE | TABLET;ORAL | 400MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0276-0508 | Metaxalone | Metaxalone | Misemer Pharmaceuticals, Inc. | ANDA | Current |
| 0904-6831 | Metaxalone | Metaxalone | Major Pharmaceuticals | ANDA | Current |
| 0904-6831 | Metaxalone | Metaxalone | Major Pharmaceuticals | ANDA | Current |
| 0904-6831 | Metaxalone | Metaxalone | Major Pharmaceuticals | ANDA | Current |
| 0904-6831 | Metaxalone | Metaxalone | Major Pharmaceuticals | ANDA | Current |
| 50090-4448 | Metaxalone | Metaxalone | A-S Medication Solutions | ANDA | Current |
| 50090-4448 | Metaxalone | Metaxalone | A-S Medication Solutions | ANDA | Current |
| 50228-323 | Metaxalone | Metaxalone | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-323 | Metaxalone | Metaxalone | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-323 | Metaxalone | Metaxalone | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-474 | Metaxalone | Metaxalone | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 55111-650 | Metaxalone | Metaxalone | Dr. Reddy | ANDA | Current |
| 55111-650 | Metaxalone | Metaxalone | Dr. Reddy | ANDA | Current |
| 55111-650 | Metaxalone | Metaxalone | Dr. Reddy | ANDA | Current |
| 60687-663 | Metaxalone | Metaxalone | American Health Packaging | ANDA | Current |
| 67296-1577 | Metaxalone | Metaxalone | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1577 | Metaxalone | Metaxalone | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1577 | Metaxalone | Metaxalone | RedPharm Drug, Inc. | ANDA | Current |
| 68001-485 | Metaxalone | Metaxalone | BluePoint Laboratories | ANDA | Current |
| 68001-485 | Metaxalone | Metaxalone | BluePoint Laboratories | ANDA | Current |
| 68788-7073 | Metaxalone | Metaxalone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7073 | Metaxalone | Metaxalone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 69336-130 | Metaxalone | Metaxalone | Sterling-Knight Pharmaceuticals, LLC | ANDA | Current |
| 71205-016 | Metaxalone | Metaxalone | Proficient Rx LP | ANDA | Current |
| 71205-016 | Metaxalone | Metaxalone | Proficient Rx LP | ANDA | Current |
| 71335-0099 | Metaxalone | Metaxalone | Bryant Ranch Prepack | ANDA | Current |
| 71335-0099 | Metaxalone | Metaxalone | Bryant Ranch Prepack | ANDA | Current |
| 71335-0099 | Metaxalone | Metaxalone | Bryant Ranch Prepack | ANDA | Current |
| 72789-028 | Metaxalone | Metaxalone | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-028 | Metaxalone | Metaxalone | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-028 | Metaxalone | Metaxalone | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-028 | Metaxalone | Metaxalone | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-028 | Metaxalone | Metaxalone | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |