Application 018829
- Type
- NDA
- Sponsor
- CHARTWELL MOLECULES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | INDOMETHACIN | INDOMETHACIN | CAPSULE;ORAL | 50MG | No | No |
| 002 | INDOMETHACIN | INDOMETHACIN | CAPSULE;ORAL | 25MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 62135-067 | INDOMETHACIN | INDOMETHACIN | Chartwell RX, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 80372 | SUPPL | 2024-11-25 |
| 80371 | SUPPL | 2024-11-25 |
| 80277 | SUPPL | 2024-11-22 |
| 67302 | SUPPL | 2021-04-30 |
| 67301 | SUPPL | 2021-04-30 |
| 67258 | SUPPL | 2021-04-29 |
| 33620 | SUPPL | 2016-05-11 |
| 16065 | SUPPL | 2016-05-11 |