Application 021605
- Type
- NDA
- Sponsor
- MERCK SHARP DOHME
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CLARINEX D 24 HOUR | DESLORATADINE; PSEUDOEPHEDRINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 5MG;240MG | Yes | Yes |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 58024 | SUPPL | 2019-03-18 |
| 58018 | SUPPL | 2019-03-18 |
| 53781 | SUPPL | 2018-04-23 |
| 53751 | SUPPL | 2018-04-20 |
| 52818 | SUPPL | 2018-03-06 |
| 52787 | SUPPL | 2018-03-01 |
| 15862 | SUPPL | 2014-03-10 |
| 5835 | SUPPL | 2014-03-10 |
| 37329 | SUPPL | 2010-01-12 |
| 5834 | SUPPL | 2010-01-05 |
| 42230 | ORIG | 2007-05-09 |
| 37328 | ORIG | 2005-03-10 |
| 5833 | ORIG | 2005-03-10 |