Drugs@FDA: FDA-Approved Drugs
Company: IMPAX LABS
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 |
---|---|---|---|---|---|---|---|
05/27/2004 | 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 |
---|---|---|---|---|---|
05/07/2024 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
06/06/2022 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
06/30/2017 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
01/04/2016 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
09/24/2014 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
09/24/2014 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
04/10/2012 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
06/24/2011 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
05/13/2010 | SUPPL-13 | REMS-Proposal |
Label is not available on this site. |
||
01/25/2010 | SUPPL-12 | Labeling-Package Insert |
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 |