Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201760
Company: SUN PHARM
Company: SUN PHARM
| 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 |
|---|---|---|---|---|---|---|---|
| 01/29/2016 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201760Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/22/2025 | SUPPL-41 | Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 02/21/2025 | SUPPL-38 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-34 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/05/2023 | SUPPL-33 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 03/20/2024 | SUPPL-32 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 12/16/2022 | SUPPL-29 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 11/16/2022 | SUPPL-27 | Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 06/17/2022 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/13/2022 | SUPPL-24 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 05/03/2022 | SUPPL-23 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 06/17/2022 | SUPPL-22 | Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/13/2022 | SUPPL-20 | Labeling-Patient Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-18 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 02/16/2021 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/09/2019 | SUPPL-12 | 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-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/31/2018 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/23/2017 | SUPPL-6 | REMS-Modified |
Label is not available on this site. |
||
| 03/24/2017 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/07/2016 | SUPPL-1 | 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 |