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 IMPAX LABS
Abbreviated New Drug Application (ANDA): 076711
Company: IMPAX LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription |
AB1 |
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 |
|---|---|---|---|---|---|---|---|
| 12/03/2004 | 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 |
|---|---|---|---|---|---|
| 01/04/2021 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/04/2021 | SUPPL-39 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/04/2021 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/04/2021 | SUPPL-31 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/04/2021 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/29/2015 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/29/2015 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/29/2015 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/29/2015 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/21/2012 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/21/2012 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/18/2010 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/08/2010 | SUPPL-11 | REMS-Proposal |
Label is not available on this site. |
||
| 01/27/2010 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/16/2008 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/05/2006 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 02/14/2006 | SUPPL-3 | Labeling |
Label is not available on this site. |
BUPROPION HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 079095 | ACTAVIS LABS FL INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 091459 | ANCHEN PHARMS |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 076711 | IMPAX LABS |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 206674 | INVAGEN PHARMS |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 202304 | PRINSTON INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 075932 | SANDOZ |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 205794 | SCIEGEN PHARMS INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 078866 | SUN PHARM |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 211347 | YICHANG HUMANWELL |
| WELLBUTRIN SR | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB1 | 020358 | GLAXOSMITHKLINE |
نظرات کاربران