Application 021312
- Type
- NDA
- Sponsor
- MERCK SHARP DOHME
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CLARINEX | DESLORATADINE | TABLET, ORALLY DISINTEGRATING;ORAL | 5MG | Yes | Yes |
| 002 | CLARINEX | DESLORATADINE | TABLET, ORALLY DISINTEGRATING;ORAL | 2.5MG | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 58021 | SUPPL | 2019-03-18 |
| 58015 | SUPPL | 2019-03-18 |
| 57899 | SUPPL | 2019-03-05 |
| 57887 | SUPPL | 2019-03-04 |
| 36634 | SUPPL | 2014-04-25 |
| 27454 | SUPPL | 2014-04-24 |
| 21592 | SUPPL | 2011-02-15 |
| 5001 | SUPPL | 2010-12-28 |
| 27453 | SUPPL | 2006-12-28 |
| 27452 | SUPPL | 2006-12-28 |
| 5000 | SUPPL | 2006-12-28 |
| 15164 | SUPPL | 2006-12-26 |
| 15165 | SUPPL | 2005-07-21 |
| 4999 | SUPPL | 2005-07-21 |
| 4998 | SUPPL | 2004-06-01 |
| 27451 | SUPPL | 2004-02-03 |
| 42092 | ORIG | 2003-11-06 |
| 27450 | ORIG | 2002-06-26 |
| 15163 | ORIG | 2002-06-26 |