Application 021991
- Type
- NDA
- Sponsor
- MERCK
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZOLINZA | VORINOSTAT | CAPSULE;ORAL | 100MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0006-0568 | ZOLINZA | vorinostat | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-0568 | ZOLINZA | vorinostat | Merck Sharp & Dohme LLC | NDA | Current |
| 0006-0568 | ZOLINZA | vorinostat | Merck Sharp & Dohme LLC | NDA | Current |
| 0006-0568 | ZOLINZA | vorinostat | Merck Sharp & Dohme LLC | NDA | Current |
| 0006-0568 | ZOLINZA | vorinostat | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-0568 | ZOLINZA | vorinostat | Merck Sharp & Dohme Corp. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 56842 | SUPPL | 2018-12-20 |
| 56711 | SUPPL | 2018-12-12 |
| 6610 | SUPPL | 2015-12-22 |
| 28993 | SUPPL | 2011-11-17 |
| 38012 | SUPPL | 2011-11-15 |
| 6609 | SUPPL | 2011-06-17 |
| 28994 | SUPPL | 2009-11-10 |
| 38013 | SUPPL | 2009-10-01 |
| 6608 | SUPPL | 2008-07-24 |
| 16704 | SUPPL | 2008-07-23 |
| 21897 | ORIG | 2006-11-20 |
| 6607 | ORIG | 2006-10-13 |
| 16703 | ORIG | 2006-10-11 |