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 APOTEX INC
Abbreviated New Drug Application (ANDA): 076143
Company: APOTEX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription |
AB |
No | No |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 01/17/2006 | 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 |
|---|---|---|---|---|---|
| 11/20/2014 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/20/2014 | SUPPL-12 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/20/2014 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/16/2012 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/21/2011 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/08/2010 | SUPPL-8 | REMS-Proposal |
Label is not available on this site. |
||
| 01/22/2010 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/01/2009 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 01/15/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/05/2006 | SUPPL-1 | Labeling |
Label is not available on this site. |
BUPROPION HYDROCHLORIDE
TABLET;ORAL; 75MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 203013 | ALEMBIC PHARMS LTD |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 075584 | APNAR PHARMA LP |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 076143 | APOTEX INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 208606 | CADILA PHARMS LTD |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 206975 | HERITAGE PHARMA |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 207389 | INVAGEN PHARMS |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 207403 | MICRO LABS |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 075491 | MYLAN |
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 203013 | ALEMBIC PHARMS LTD |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 075584 | APNAR PHARMA LP |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 076143 | APOTEX INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 208606 | CADILA PHARMS LTD |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 206975 | HERITAGE PHARMA |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 207389 | INVAGEN PHARMS |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 207403 | MICRO LABS |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 075491 | MYLAN |
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