Application 205637
- Type
- NDA
- Sponsor
- BDSI
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUNAVAIL | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | FILM;BUCCAL | EQ 2.1MG BASE;EQ 0.3MG BASE | Yes | No |
| 002 | BUNAVAIL | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | FILM;BUCCAL | EQ 4.2MG BASE;EQ 0.7MG BASE | Yes | No |
| 003 | BUNAVAIL | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | FILM;BUCCAL | EQ 6.3MG BASE;EQ 1MG BASE | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 59385-012 | BUNAVAIL | buprenorphine and naloxone | BioDelivery Sciences International, Inc. | NDA | Current |
| 59385-012 | BUNAVAIL | buprenorphine and naloxone | BioDelivery Sciences International, Inc. | NDA | Current |
| 59385-012 | BUNAVAIL | buprenorphine and naloxone | BioDelivery Sciences International, Inc. | NDA | Current |
| 59385-014 | BUNAVAIL | buprenorphine and naloxone | BioDelivery Sciences International, Inc. | NDA | Current |
| 59385-014 | BUNAVAIL | buprenorphine and naloxone | BioDelivery Sciences International, Inc. | NDA | Current |
| 59385-014 | BUNAVAIL | buprenorphine and naloxone | BioDelivery Sciences International, Inc. | NDA | Current |
| 59385-014 | BUNAVAIL | buprenorphine and naloxone | BioDelivery Sciences International, Inc. | NDA | Current |
| 59385-016 | BUNAVAIL | buprenorphine and naloxone | BioDelivery Sciences International, Inc. | NDA | Current |
| 59385-016 | BUNAVAIL | buprenorphine and naloxone | BioDelivery Sciences International, Inc. | NDA | Current |
| 59385-016 | BUNAVAIL | buprenorphine and naloxone | BioDelivery Sciences International, Inc. | NDA | Current |
| 59385-016 | BUNAVAIL | buprenorphine and naloxone | BioDelivery Sciences International, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 73063 | SUPPL | 2022-12-29 |
| 71400 | SUPPL | 2022-06-21 |
| 71398 | SUPPL | 2022-06-21 |
| 71377 | SUPPL | 2022-06-21 |
| 71376 | SUPPL | 2022-06-21 |
| 70975 | SUPPL | 2022-05-04 |
| 66651 | SUPPL | 2021-03-08 |
| 66650 | SUPPL | 2021-03-08 |
| 66612 | SUPPL | 2021-03-08 |
| 60484 | SUPPL | 2019-10-09 |
| 60483 | SUPPL | 2019-10-09 |
| 60462 | SUPPL | 2019-10-09 |
| 56298 | SUPPL | 2018-11-06 |
| 52291 | SUPPL | 2018-02-02 |
| 52241 | SUPPL | 2018-02-01 |
| 48522 | SUPPL | 2017-05-25 |
| 48184 | SUPPL | 2017-05-02 |
| 48183 | SUPPL | 2017-05-02 |
| 48167 | SUPPL | 2017-04-28 |
| 48166 | SUPPL | 2017-04-28 |
| 46435 | SUPPL | 2016-12-21 |
| 46325 | SUPPL | 2016-12-20 |
| 32697 | SUPPL | 2016-07-11 |
| 24499 | ORIG | 2015-05-28 |
| 22998 | ORIG | 2015-05-28 |
| 10483 | SUPPL | 2015-02-17 |
| 44597 | ORIG | 2015-01-08 |
| 19670 | ORIG | 2014-06-10 |
| 10482 | ORIG | 2014-06-10 |