Application 205108
- Type
- NDA
- Sponsor
- ARBOR PHARMS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SOTYLIZE | SOTALOL HYDROCHLORIDE | SOLUTION;ORAL | 5MG/ML (5MG/ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 24338-530 | SOTYLIZE | SOTALOL HYDROCHLORIDE | Arbor Pharmaceuticals, Inc. | NDA | Current |