Application 211950
- Type
- NDA
- Sponsor
- CLEARSIDE BIOMEDICAL, INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | XIPERE | TRIAMCINOLONE ACETONIDE | INJECTABLE; SUSPENSION | 40MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 24208-040 | Xipere | triamcinolone acetonide | Bausch & Lomb Incorporated | NDA | Current |
| 24208-040 | Xipere | triamcinolone acetonide | Bausch & Lomb Incorporated | NDA | Current |
| 24208-040 | Xipere | triamcinolone acetonide | Bausch & Lomb Incorporated | NDA | Current |
| 71565-040 | Xipere | triamcinolone acetonide | Clearside Biomedical, Inc. | NDA | Current |
| 71565-040 | Xipere | triamcinolone acetonide | Clearside Biomedical, Inc. | NDA | Current |
| 71565-040 | Xipere | triamcinolone acetonide | Clearside Biomedical, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82414 | SUPPL | 2025-06-02 |
| 82316 | SUPPL | 2025-05-27 |
| 72235 | ORIG | 2022-10-04 |
| 69105 | ORIG | 2021-10-25 |
| 69104 | ORIG | 2021-10-25 |