Application 021137
- Type
- NDA
- Sponsor
- GENUS LIFESCIENCES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LEVOLET | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.025MG | No | No |
| 002 | LEVOLET | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.05MG | No | No |
| 003 | LEVOLET | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.075MG | No | No |
| 004 | LEVOLET | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.088MG | No | No |
| 005 | LEVOLET | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.1MG | No | No |
| 006 | LEVOLET | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.112MG | No | No |
| 007 | LEVOLET | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.125MG | No | No |
| 008 | LEVOLET | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.137MG | No | No |
| 009 | LEVOLET | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.15MG | No | No |
| 010 | LEVOLET | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.175MG | No | No |
| 011 | LEVOLET | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.2MG | No | No |
| 012 | LEVOLET | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.3MG | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 71742 | SUPPL | 2022-08-08 |
| 69712 | SUPPL | 2021-12-21 |
| 69711 | SUPPL | 2021-12-21 |
| 69710 | SUPPL | 2021-12-21 |
| 69632 | SUPPL | 2021-12-19 |
| 69631 | SUPPL | 2021-12-19 |
| 69630 | SUPPL | 2021-12-19 |
| 14481 | ORIG | 2004-06-08 |
| 41978 | ORIG | 2004-06-04 |
| 26884 | ORIG | 2003-06-08 |