Application 208271
- Type
- NDA
- Sponsor
- SALIX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RELISTOR | METHYLNALTREXONE BROMIDE | TABLET;ORAL | 150MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 65649-150 | Relistor | Methylnaltrexone bromide | Salix Pharmaceuticals, Inc. | NDA | Current |
| 65649-150 | Relistor | Methylnaltrexone bromide | Salix Pharmaceuticals, Inc. | NDA | Current |
| 65649-150 | Relistor | Methylnaltrexone bromide | Salix Pharmaceuticals, Inc. | NDA | Current |
| 65649-150 | Relistor | Methylnaltrexone bromide | Salix Pharmaceuticals, Inc. | NDA | Current |
| 65649-150 | Relistor | Methylnaltrexone bromide | Salix Pharmaceuticals, Inc. | NDA | Current |
| 65649-150 | Relistor | Methylnaltrexone bromide | Salix Pharmaceuticals, Inc. | NDA | Current |