Application 020668
- Type
- NDA
- Sponsor
- ASTRAZENECA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEXXEL | ENALAPRIL MALEATE; FELODIPINE | TABLET, EXTENDED RELEASE;ORAL | 5MG;5MG | No | No |
| 002 | LEXXEL | ENALAPRIL MALEATE; FELODIPINE | TABLET, EXTENDED RELEASE;ORAL | 5MG;2.5MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 20812 | SUPPL | 2008-02-19 |
| 3051 | SUPPL | 2007-10-10 |
| 41535 | SUPPL | 2007-07-06 |
| 20810 | SUPPL | 2007-07-06 |
| 13177 | SUPPL | 2005-08-04 |
| 3048 | SUPPL | 2005-08-04 |
| 3050 | SUPPL | 2004-12-29 |
| 25483 | SUPPL | 2004-06-10 |
| 13178 | SUPPL | 2004-06-10 |
| 3049 | SUPPL | 2003-06-22 |
| 20811 | SUPPL | 2002-07-25 |
| 35119 | SUPPL | 1998-10-28 |
| 3047 | SUPPL | 1998-10-28 |