Application 020863
- Type
- NDA
- Sponsor
- OTSUKA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PLETAL | CILOSTAZOL | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | PLETAL | CILOSTAZOL | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 48454 | SUPPL | 2017-05-19 |
| 48449 | SUPPL | 2017-05-18 |
| 13637 | SUPPL | 2015-08-04 |
| 26076 | SUPPL | 2015-07-31 |
| 13636 | SUPPL | 2015-01-29 |
| 26075 | SUPPL | 2015-01-26 |
| 13635 | SUPPL | 2007-11-19 |
| 3601 | SUPPL | 2007-11-19 |
| 26074 | SUPPL | 2007-01-25 |
| 13634 | SUPPL | 2007-01-24 |
| 35526 | SUPPL | 2005-11-30 |
| 26073 | SUPPL | 2005-11-30 |
| 13633 | ORIG | 2004-06-14 |
| 3600 | SUPPL | 2004-03-03 |
| 21027 | ORIG | 1999-01-15 |
| 3599 | ORIG | 1999-01-15 |