Application 040486
- Type
- ANDA
- Sponsor
- MOUNTAIN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METAXALONE | METAXALONE | TABLET;ORAL | 400MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0115-1745 | Metaxalone | Metaxalone | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1745 | Metaxalone | Metaxalone | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1745 | Metaxalone | Metaxalone | Impax Generics | ANDA | Current |
| 0115-1745 | Metaxalone | Metaxalone | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 68387-108 | Metaxalone | Metaxalone | Keltman Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 29960 | ORIG | 2015-03-04 |