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 MYLAN
Abbreviated New Drug Application (ANDA): 075491
Company: MYLAN
| 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 | 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 |
|---|---|---|---|---|---|---|---|
| 04/17/2000 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75491ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/22/2015 | SUPPL-31 | Labeling-Medication Guide |
Label is not available on this site. |
||
| 05/22/2015 | SUPPL-30 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/14/2014 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/07/2014 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/07/2014 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/22/2010 | SUPPL-24 | REMS-Proposal |
Label is not available on this site. |
||
| 12/10/2009 | SUPPL-23 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/26/2009 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 09/08/2008 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 01/16/2008 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 01/16/2008 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 05/01/2007 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 02/06/2006 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 04/08/2005 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/06/2004 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 08/26/2002 | SUPPL-2 | 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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