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 HERITAGE PHARMA
Abbreviated New Drug Application (ANDA): 075310
Company: HERITAGE PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 75MG | TABLET;ORAL | Discontinued |
None |
No | No |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 11/29/1999 | 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 |
|---|---|---|---|---|---|
| 08/09/2010 | SUPPL-22 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 08/09/2010 | SUPPL-21 | REMS-Proposal |
Label is not available on this site. |
||
| 11/05/2009 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/02/2009 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 02/26/2009 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 01/16/2008 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 01/16/2008 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 05/21/2007 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 08/26/2005 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 04/08/2005 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 04/08/2005 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 07/16/2003 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 07/16/2003 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 09/27/2001 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 11/16/2000 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 02/12/2001 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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