Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077475
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB2 | 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 |
|---|---|---|---|---|---|---|---|
| 03/12/2008 | 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 |
|---|---|---|---|---|---|
| 11/06/2025 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/07/2024 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/18/2021 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/30/2017 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/30/2017 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/10/2015 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/10/2015 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/16/2013 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/09/2012 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/22/2011 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/25/2010 | SUPPL-7 | REMS-Proposal |
Label is not available on this site. |
||
| 01/25/2010 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/23/2008 | SUPPL-1 | Labeling |
Label is not available on this site. |
BUPROPION HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL; 150MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 079094 | ACTAVIS LABS FL INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 075914 | IMPAX LABS |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 077475 | SANDOZ |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 206122 | SCIEGEN PHARMS |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 216766 | YICHANG HUMANWELL |