Application 209819
- Type
- NDA
- Sponsor
- INDIVIOR INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SUBLOCADE | BUPRENORPHINE | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | 100MG/0.5ML (100MG/0.5ML) | Yes | No |
| 002 | SUBLOCADE | BUPRENORPHINE | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | 300MG/1.5ML (200MG/ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 12496-0100 | SUBLOCADE | buprenorphine | Indivior Inc. | NDA | Current |
| 12496-0100 | SUBLOCADE | buprenorphine | Indivior Inc. | NDA | Current |
| 12496-0100 | SUBLOCADE | buprenorphine | Indivior Inc. | NDA | Current |
| 12496-0100 | SUBLOCADE | buprenorphine | Indivior Inc. | NDA | Current |
| 12496-0100 | SUBLOCADE | buprenorphine | Indivior Inc. | NDA | Current |
| 12496-0100 | SUBLOCADE | buprenorphine | Indivior Inc. | NDA | Current |
| 12496-0100 | SUBLOCADE | buprenorphine | Indivior Inc. | NDA | Current |
| 12496-0100 | SUBLOCADE | buprenorphine | Indivior Inc. | NDA | Current |
| 12496-0100 | SUBLOCADE | buprenorphine | Indivior Inc. | NDA | Current |
| 12496-0100 | SUBLOCADE | buprenorphine | Indivior Inc. | NDA | Current |
| 12496-0300 | SUBLOCADE | buprenorphine | Indivior Inc. | NDA | Current |
| 12496-0300 | SUBLOCADE | buprenorphine | Indivior Inc. | NDA | Current |
| 12496-0300 | SUBLOCADE | buprenorphine | Indivior Inc. | NDA | Current |
| 12496-0300 | SUBLOCADE | buprenorphine | Indivior Inc. | NDA | Current |
| 12496-0300 | SUBLOCADE | buprenorphine | Indivior Inc. | NDA | Current |
| 12496-0300 | SUBLOCADE | buprenorphine | Indivior Inc. | NDA | Current |
| 12496-0300 | SUBLOCADE | buprenorphine | Indivior Inc. | NDA | Current |
| 12496-0300 | SUBLOCADE | buprenorphine | Indivior Inc. | NDA | Current |
| 12496-0300 | SUBLOCADE | buprenorphine | Indivior Inc. | NDA | Current |
| 12496-0300 | SUBLOCADE | buprenorphine | Indivior Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84656 | SUPPL | 2026-01-06 |
| 84584 | SUPPL | 2025-12-29 |
| 83608 | SUPPL | 2025-09-30 |
| 81338 | SUPPL | 2025-09-30 |
| 81942 | SUPPL | 2025-04-21 |
| 81339 | SUPPL | 2025-02-24 |
| 78192 | SUPPL | 2024-04-22 |
| 77059 | SUPPL | 2023-12-19 |
| 76968 | SUPPL | 2023-12-18 |
| 76280 | ORIG | 2023-11-03 |
| 75658 | SUPPL | 2023-10-03 |
| 75650 | SUPPL | 2023-10-03 |
| 74688 | SUPPL | 2023-07-05 |
| 73756 | SUPPL | 2023-03-14 |
| 73743 | SUPPL | 2023-03-14 |
| 73122 | SUPPL | 2023-01-09 |
| 71894 | SUPPL | 2022-08-25 |
| 71875 | SUPPL | 2022-08-24 |
| 71411 | SUPPL | 2022-06-21 |
| 71382 | SUPPL | 2022-06-21 |
| 68799 | SUPPL | 2021-09-28 |
| 67878 | SUPPL | 2021-06-23 |
| 67877 | SUPPL | 2021-06-23 |
| 67868 | SUPPL | 2021-06-23 |
| 67469 | SUPPL | 2021-05-12 |
| 67456 | SUPPL | 2021-05-12 |
| 66541 | SUPPL | 2021-03-08 |
| 66532 | SUPPL | 2021-03-08 |
| 66536 | SUPPL | 2021-03-05 |
| 66535 | SUPPL | 2021-03-05 |
| 66534 | SUPPL | 2021-03-05 |
| 66533 | SUPPL | 2021-03-05 |
| 63585 | SUPPL | 2020-06-17 |
| 61997 | SUPPL | 2020-02-28 |
| 61996 | SUPPL | 2020-02-28 |
| 61780 | SUPPL | 2020-02-05 |
| 60318 | SUPPL | 2019-10-08 |
| 60290 | SUPPL | 2019-10-08 |
| 55867 | ORIG | 2018-10-11 |
| 53069 | ORIG | 2018-03-21 |
| 52999 | SUPPL | 2018-03-15 |
| 52851 | SUPPL | 2018-03-08 |
| 50576 | ORIG | 2017-12-01 |
| 50537 | ORIG | 2017-12-01 |