Application 078367
- Type
- ANDA
- Sponsor
- REDDYS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DESLORATADINE | DESLORATADINE | TABLET, ORALLY DISINTEGRATING;ORAL | 2.5MG | No | No |
| 002 | DESLORATADINE | DESLORATADINE | TABLET, ORALLY DISINTEGRATING;ORAL | 5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55111-360 | Desloratadine | Desloratadine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-360 | Desloratadine | Desloratadine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-551 | Desloratadine | Desloratadine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-551 | Desloratadine | Desloratadine | Dr. Reddy's Laboratories Limited | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31361 | ORIG | 2010-07-14 |