Application 208845
- Type
- NDA
- Sponsor
- FLEXION THERAPS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZILRETTA | TRIAMCINOLONE ACETONIDE | FOR SUSPENSION, EXTENDED RELEASE;INTRA-ARTICULAR | 32MG/VIAL | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65250-003 | Zilretta | triamcinolone acetonide extended-release injectable suspension | Pacira Pharmaceuticals, Inc. | NDA | Current |
| 70801-003 | Zilretta | triamcinolone acetonide extended-release injectable suspension | Flexion Therapeutics, Inc. | NDA | Current |
| 70801-003 | Zilretta | triamcinolone acetonide extended-release injectable suspension | Flexion Therapeutics, Inc. | NDA | Current |
| 70801-003 | Zilretta | triamcinolone acetonide extended-release injectable suspension | Flexion Therapeutics, Inc. | NDA | Current |
| 70801-003 | Zilretta | triamcinolone acetonide extended-release injectable suspension | Flexion Therapeutics, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 80511 | SUPPL | 2024-12-05 |
| 80498 | SUPPL | 2024-12-04 |
| 79555 | SUPPL | 2024-09-06 |
| 79554 | SUPPL | 2024-09-06 |
| 65499 | SUPPL | 2020-12-04 |
| 65489 | SUPPL | 2020-12-03 |
| 61486 | SUPPL | 2019-12-31 |
| 61455 | SUPPL | 2019-12-26 |
| 53645 | ORIG | 2018-04-10 |
| 50022 | ORIG | 2017-10-12 |
| 49996 | ORIG | 2017-10-10 |