Application 020740
- Type
- NDA
- Sponsor
- BAYER PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BAYCOL | CERIVASTATIN SODIUM | TABLET;ORAL | 0.05MG | No | No |
| 002 | BAYCOL | CERIVASTATIN SODIUM | TABLET;ORAL | 0.1MG | No | No |
| 003 | BAYCOL | CERIVASTATIN SODIUM | TABLET;ORAL | 0.2MG | No | No |
| 004 | BAYCOL | CERIVASTATIN SODIUM | TABLET;ORAL | 0.3MG | No | No |
| 005 | BAYCOL | CERIVASTATIN SODIUM | TABLET;ORAL | 0.4MG | No | No |
| 006 | BAYCOL | CERIVASTATIN SODIUM | TABLET;ORAL | 0.8MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 13316 | ORIG | 2010-03-02 |
| 20891 | SUPPL | 2008-02-19 |
| 41631 | SUPPL | 2007-09-24 |
| 41630 | SUPPL | 2007-09-24 |
| 20889 | SUPPL | 2007-09-24 |
| 35251 | SUPPL | 2003-04-22 |
| 35252 | SUPPL | 2002-04-23 |
| 41634 | SUPPL | 2001-12-03 |
| 41633 | SUPPL | 2001-12-03 |
| 41628 | SUPPL | 2001-12-03 |
| 20890 | SUPPL | 2001-12-03 |
| 41632 | SUPPL | 2001-11-29 |
| 41629 | SUPPL | 2001-11-29 |
| 20888 | SUPPL | 2001-11-29 |
| 20887 | SUPPL | 2001-11-29 |
| 35250 | SUPPL | 2001-03-30 |
| 25666 | SUPPL | 2001-03-30 |
| 3236 | SUPPL | 2000-07-23 |
| 3235 | SUPPL | 2000-07-23 |
| 13318 | SUPPL | 2000-07-21 |
| 13317 | SUPPL | 2000-07-21 |
| 25665 | SUPPL | 1999-05-24 |