Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090279
Company: RUBICON RESEARCH
Company: RUBICON RESEARCH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET;SUBLINGUAL | Prescription | AB | No | No |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET;SUBLINGUAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/10/2015 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/02/2026 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/21/2025 | SUPPL-25 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/26/2023 | SUPPL-22 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 03/20/2024 | SUPPL-21 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 12/16/2022 | SUPPL-19 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 06/26/2023 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/17/2022 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/03/2022 | SUPPL-14 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 06/17/2022 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/13/2022 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/09/2019 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/31/2018 | SUPPL-9 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 02/01/2018 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/23/2017 | SUPPL-7 | REMS-Modified |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/07/2016 | SUPPL-4 | REMS-Modified |
Label is not available on this site. |
BUPRENORPHINE HYDROCHLORIDE
TABLET;SUBLINGUAL; EQ 2MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 090819 | ACTAVIS ELIZABETH |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 219401 | ASCENT PHARMS INC |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 090622 | ETHYPHARM |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 078633 | HIKMA |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 207276 | RHODES PHARMS |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 090279 | RUBICON RESEARCH |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 218473 | SPECGX LLC |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 201760 | SUN PHARM |
TABLET;SUBLINGUAL; EQ 8MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 090819 | ACTAVIS ELIZABETH |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 219401 | ASCENT PHARMS INC |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 090622 | ETHYPHARM |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 078633 | HIKMA |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 207276 | RHODES PHARMS |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 090279 | RUBICON RESEARCH |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 218473 | SPECGX LLC |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 201760 | SUN PHARM |