Skip to contentApplication 075663
- Type
- ANDA
- Sponsor
- IMPAX PHARMS
Application Products#
Product, Drug, Ingredient table| 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 |
| 004 | SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | TABLET;ORAL | 240MG | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 43017 | ORIG | 2005-07-22 |
| 30979 | ORIG | 2000-11-07 |