Application 212157
- Type
- NDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ELYXYB | CELECOXIB | SOLUTION;ORAL | 120MG/4.8ML(25MG/ML) | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 43598-866 | ELYXYB | Celecoxib | Dr. Reddy | NDA | Current |
| 59385-055 | ELYXYB - celecoxib | celecoxib | BioDelivery Sciences International Inc | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 80405 | SUPPL | 2024-11-25 |
| 80404 | SUPPL | 2024-11-25 |
| 80319 | SUPPL | 2024-11-22 |
| 67351 | SUPPL | 2021-05-03 |
| 67296 | SUPPL | 2021-04-30 |
| 64110 | ORIG | 2020-07-28 |
| 62836 | ORIG | 2020-05-06 |
| 62827 | ORIG | 2020-05-05 |
| 62826 | ORIG | 2020-05-05 |