Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205954
Company: ALVOGEN
Company: ALVOGEN
| 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 | FILM;BUCCAL, SUBLINGUAL | Prescription | AB | No | No |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 4MG BASE;EQ 1MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | AB | No | No |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | AB | No | No |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM;BUCCAL, 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 |
|---|---|---|---|---|---|---|---|
| 01/24/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/20/2024 | SUPPL-26 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 05/23/2023 | SUPPL-23 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2022 | SUPPL-22 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 05/23/2023 | SUPPL-21 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/03/2022 | SUPPL-19 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 05/23/2023 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
FILM;BUCCAL, 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 | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 205954 | ALVOGEN |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 205299 | DR REDDYS LABS SA |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 211785 | MYLAN TECHNOLOGIES |
| SUBOXONE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | Yes | AB | 022410 | INDIVIOR |
FILM;BUCCAL, SUBLINGUAL; EQ 4MG BASE;EQ 1MG 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 4MG BASE;EQ 1MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 205954 | ALVOGEN |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 4MG BASE;EQ 1MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 205806 | DR REDDYS LABS SA |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 4MG BASE;EQ 1MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 211785 | MYLAN TECHNOLOGIES |
| SUBOXONE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 4MG BASE;EQ 1MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | Yes | AB | 022410 | INDIVIOR |
FILM;BUCCAL, SUBLINGUAL; EQ 8MG BASE;EQ 2MG 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 8MG BASE;EQ 2MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 205954 | ALVOGEN |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 212756 | AVEVA |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 205299 | DR REDDYS LABS SA |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 207607 | MYLAN TECHNOLOGIES |
| SUBOXONE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | Yes | AB | 022410 | INDIVIOR |
FILM;BUCCAL, SUBLINGUAL; EQ 12MG BASE;EQ 3MG 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 12MG BASE;EQ 3MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 205954 | ALVOGEN |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 212756 | AVEVA |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 205806 | DR REDDYS LABS SA |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | No | AB | 207607 | MYLAN TECHNOLOGIES |
| SUBOXONE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM;BUCCAL, SUBLINGUAL | Prescription | Yes | AB | 022410 | INDIVIOR |