Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203136
Company: AMNEAL PHARMS
Company: AMNEAL PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | TABLET;SUBLINGUAL | Prescription | AB | No | No |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG 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 |
|---|---|---|---|---|---|---|---|
| 02/22/2013 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203136Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-46 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/25/2023 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/20/2024 | SUPPL-43 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 12/16/2022 | SUPPL-42 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 06/17/2022 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/03/2022 | SUPPL-38 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 06/17/2022 | SUPPL-37 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/14/2022 | SUPPL-35 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-30 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/14/2021 | SUPPL-26 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/14/2021 | SUPPL-25 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/08/2019 | SUPPL-21 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/31/2018 | SUPPL-19 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 02/01/2018 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/01/2018 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/31/2018 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/23/2017 | SUPPL-13 | REMS-Modified |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/07/2016 | SUPPL-9 | REMS-Modified |
Label is not available on this site. |
||
| 02/05/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/12/2015 | SUPPL-6 | REMS-Proposal |
Label is not available on this site. |
||
| 09/04/2013 | SUPPL-5 | REMS-Proposal |
Label is not available on this site. |
||
| 04/18/2014 | SUPPL-3 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203136Orig1s003ltr.pdf |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
TABLET;SUBLINGUAL; EQ 2MG BASE;EQ 0.5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 091422 | ACTAVIS ELIZABETH |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 214930 | ALKEM LABS LTD |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 203136 | AMNEAL PHARMS |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 204431 | ETHYPHARM USA CORP |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 203326 | HIKMA |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 205022 | LANNETT CO INC |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 205601 | RHODES PHARMS |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 207000 | SPECGX LLC |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 201633 | SUN PHARM |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | TABLET;SUBLINGUAL | Prescription | No | AB | 209069 | WES PHARMA INC |