Application 021165
- Type
- NDA
- Sponsor
- MERCK SHARP DOHME
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CLARINEX | DESLORATADINE | TABLET;ORAL | 5MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0085-1264 | Clarinex | Desloratadine | Merck Sharp & Dohme Corp. | NDA | Current |
| 0085-1264 | Clarinex | Desloratadine | Merck Sharp & Dohme Corp. | NDA | Current |
| 0085-1264 | Clarinex | Desloratadine | Merck Sharp & Dohme Corp. | NDA | Current |
| 0085-1264 | Clarinex | Desloratadine | Merck Sharp & Dohme Corp. | NDA | Current |
| 0085-1264 | Clarinex | Desloratadine | Merck Sharp & Dohme Corp. | NDA | Current |
| 50090-0765 | Clarinex | Desloratadine | A-S Medication Solutions | NDA | Current |
| 78206-119 | Clarinex | Desloratadine | Organon LLC | NDA | Current |
| 78206-119 | Clarinex | Desloratadine | Organon LLC | NDA | Current |
| 78206-119 | Clarinex | Desloratadine | Organon LLC | NDA | Current |
| 78206-119 | Clarinex | Desloratadine | Organon LLC | NDA | Current |
| 78206-188 | Clarinex | Desloratadine | Organon LLC | NDA | Current |
| 78206-188 | Clarinex | Desloratadine | Organon LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 58217 | SUPPL | 2019-04-04 |
| 58013 | SUPPL | 2019-03-18 |
| 57897 | SUPPL | 2019-03-05 |
| 57885 | SUPPL | 2019-03-04 |
| 36253 | SUPPL | 2014-04-25 |
| 4517 | SUPPL | 2014-04-24 |
| 14542 | SUPPL | 2012-05-03 |
| 4516 | SUPPL | 2010-12-28 |
| 26953 | SUPPL | 2006-12-28 |
| 4515 | SUPPL | 2006-12-28 |
| 4514 | SUPPL | 2006-12-28 |
| 36252 | SUPPL | 2004-06-01 |
| 4513 | SUPPL | 2004-02-03 |
| 41998 | SUPPL | 2003-07-08 |
| 26952 | SUPPL | 2002-02-08 |
| 41997 | ORIG | 2001-12-21 |
| 26951 | ORIG | 2001-12-21 |
| 14541 | ORIG | 2001-12-21 |