Application 021300
- Type
- NDA
- Sponsor
- MERCK SHARP DOHME
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CLARINEX | DESLORATADINE | SOLUTION;ORAL | 0.5MG/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0085-1334 | Clarinex | Desloratadine | Merck Sharp & Dohme Corp. | NDA | Current |
| 0085-1334 | Clarinex | Desloratadine | Merck Sharp & Dohme Corp. | NDA | Current |
| 0085-1334 | Clarinex | Desloratadine | Merck Sharp & Dohme Corp. | NDA | Current |
| 0085-1334 | Clarinex | Desloratadine | Merck Sharp & Dohme Corp. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 58022 | SUPPL | 2019-03-18 |
| 58014 | SUPPL | 2019-03-18 |
| 57898 | SUPPL | 2019-03-05 |
| 57886 | SUPPL | 2019-03-04 |
| 15133 | SUPPL | 2014-04-25 |
| 4961 | SUPPL | 2014-04-24 |
| 27414 | SUPPL | 2010-12-28 |
| 27413 | SUPPL | 2006-12-28 |
| 27412 | SUPPL | 2006-12-28 |
| 4960 | SUPPL | 2006-12-28 |
| 42089 | ORIG | 2006-07-25 |
| 36608 | ORIG | 2004-09-03 |
| 4959 | ORIG | 2004-09-03 |