Application 019151
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RYTHMOL | PROPAFENONE HYDROCHLORIDE | TABLET;ORAL | 150MG | Yes | No |
| 002 | RYTHMOL | PROPAFENONE HYDROCHLORIDE | TABLET;ORAL | 300MG | Yes | No |
| 003 | RYTHMOL | PROPAFENONE HYDROCHLORIDE | TABLET;ORAL | 225MG | Yes | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 56326 | SUPPL | 2018-11-07 |
| 56255 | SUPPL | 2018-11-02 |
| 33701 | SUPPL | 2013-03-26 |
| 1236 | SUPPL | 2013-03-22 |
| 1235 | SUPPL | 2004-06-16 |
| 1234 | SUPPL | 2002-12-05 |
| 20208 | SUPPL | 1997-12-23 |