Skip to contentApplication 210730
- Type
- NDA
- Sponsor
- TREVENA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OLINVYK | OLICERIDINE | INJECTABLE;INTRAVENOUS | 1.5MG | No | No |
| 002 | OLINVYK | OLICERIDINE | SOLUTION;INTRAVENOUS | 2MG/2ML (1MG/ML) | Yes | Yes |
| 003 | OLINVYK | OLICERIDINE | SOLUTION;INTRAVENOUS | 30MG/30ML (1MG/ML) | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 71308-011 | OLINVYK | OLICERIDINE | Trevena, Inc. | NDA | Current |
| 71308-011 | OLINVYK | OLICERIDINE | Trevena, Inc. | NDA | Current |
| 71308-011 | OLINVYK | OLICERIDINE | Trevena, Inc. | NDA | Current |
| 71308-011 | OLINVYK | OLICERIDINE | Trevena, Inc. | NDA | Current |
| 71308-021 | OLINVYK | OLICERIDINE | Trevena, Inc. | NDA | Current |
| 71308-021 | OLINVYK | OLICERIDINE | Trevena, Inc. | NDA | Current |
| 71308-021 | OLINVYK | OLICERIDINE | Trevena, Inc. | NDA | Current |
| 71308-021 | OLINVYK | OLICERIDINE | Trevena, Inc. | NDA | Current |
| 71308-301 | OLINVYK | OLICERIDINE | Trevena, Inc. | NDA | Current |
| 71308-301 | OLINVYK | OLICERIDINE | Trevena, Inc. | NDA | Current |
| 71308-301 | OLINVYK | OLICERIDINE | Trevena, Inc. | NDA | Current |
| 71308-301 | OLINVYK | OLICERIDINE | Trevena, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84654 | SUPPL | 2026-01-06 |
| 84540 | SUPPL | 2025-12-23 |
| 77060 | SUPPL | 2023-12-19 |
| 76971 | SUPPL | 2023-12-18 |
| 68935 | ORIG | 2021-10-08 |
| 66545 | SUPPL | 2021-03-05 |
| 66543 | SUPPL | 2021-03-05 |
| 64493 | ORIG | 2020-09-04 |
| 64247 | ORIG | 2020-08-10 |
| 64245 | ORIG | 2020-08-10 |