Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079094
Company: ACTAVIS LABS FL INC
Company: ACTAVIS LABS FL INC
| 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 | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/24/2009 | 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 |
|---|---|---|---|---|---|
| 04/03/2024 | SUPPL-35 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/03/2024 | SUPPL-33 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/03/2024 | SUPPL-30 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/30/2017 | SUPPL-24 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 06/14/2015 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/14/2015 | SUPPL-20 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 06/14/2015 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/16/2013 | SUPPL-12 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 04/18/2012 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/27/2010 | SUPPL-8 | REMS-Proposal |
Label is not available on this site. |
||
| 11/16/2009 | SUPPL-5 | Labeling-Package Insert, Labeling-Medication Guide |
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 INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 216766 | YICHANG HUMANWELL |