Application 208042
- Type
- NDA
- Sponsor
- TEVA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CASSIPA | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | FILM;SUBLINGUAL | EQ 16MG BASE;EQ 4MG BASE | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 77896 | SUPPL | 2024-03-21 |
| 77079 | SUPPL | 2023-12-19 |
| 76938 | SUPPL | 2023-12-18 |
| 76937 | SUPPL | 2023-12-18 |
| 76391 | ORIG | 2023-11-06 |
| 73856 | SUPPL | 2023-03-24 |
| 73838 | SUPPL | 2023-03-24 |
| 73837 | SUPPL | 2023-03-24 |
| 73064 | SUPPL | 2022-12-29 |
| 71402 | SUPPL | 2022-06-21 |
| 71401 | SUPPL | 2022-06-21 |
| 71381 | SUPPL | 2022-06-21 |
| 71380 | SUPPL | 2022-06-21 |
| 70982 | SUPPL | 2022-05-04 |
| 66615 | SUPPL | 2021-03-08 |
| 66538 | SUPPL | 2021-03-05 |
| 66537 | SUPPL | 2021-03-05 |
| 60486 | SUPPL | 2019-10-09 |
| 60485 | SUPPL | 2019-10-09 |
| 60464 | SUPPL | 2019-10-09 |
| 58461 | ORIG | 2019-04-29 |
| 57216 | APPL | 2019-01-14 |
| 55438 | ORIG | 2018-09-12 |
| 55414 | ORIG | 2018-09-10 |