اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BUPROPION HYDROCHLORIDE از شرکت WATSON LABS INC
Abbreviated New Drug Application (ANDA): 077455
Company: WATSON LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued |
None |
No | No |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued |
None |
No | No |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued |
None |
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 |
|---|---|---|---|---|---|
| 01/04/2021 | SUPPL-27 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/04/2021 | SUPPL-25 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/14/2014 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/11/2013 | SUPPL-20 | REMS-Modified |
Label is not available on this site. |
||
| 04/16/2012 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/22/2010 | SUPPL-11 | REMS-Proposal |
Label is not available on this site. |
||
| 11/16/2009 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/26/2009 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 07/19/2010 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 09/23/2008 | SUPPL-1 | Labeling |
Label is not available on this site. |
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