Application 077616
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | TABLET;ORAL | 80MG | No | No |
| 002 | SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | TABLET;ORAL | 120MG | No | No |
| 003 | SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | TABLET;ORAL | 160MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-5123 | Sotalol Hydrochloride | sotalol hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5124 | Sotalol Hydrochloride | sotalol hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5125 | Sotalol Hydrochloride | sotalol hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |