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): 077415
Company: IMPAX LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription |
AB3 |
No | No |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 300MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/15/2006 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077415TAltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/07/2020 | SUPPL-36 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 09/26/2017 | SUPPL-33 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/26/2017 | SUPPL-32 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/26/2017 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/01/2014 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/29/2012 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/077415Orig1s018.pdf |
|
| 08/30/2011 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/077415Orig1s017.pdf |
|
| 05/13/2010 | SUPPL-15 | REMS-Proposal |
Label is not available on this site. |
||
| 01/22/2010 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2009 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/26/2008 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 11/26/2008 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/10/2008 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 09/17/2007 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/17/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |
BUPROPION HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL; 150MG
TE Code = AB3
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 210497 | ACCORD HLTHCARE |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 077715 | ACTAVIS LABS FL INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 211020 | ADAPTIS |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 207224 | ANBISON LAB |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 077284 | ANCHEN PHARMS |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 077415 | IMPAX LABS |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 206556 | INVAGEN PHARMS |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 090693 | LUPIN LTD |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 207479 | SCIEGEN PHARMS INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 208652 | SINOTHERAPEUTICS INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 200216 | SUN PHARM |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 210081 | TWI PHARMS |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 077285 | WATSON LABS INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 202189 | WOCKHARDT LTD |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 210015 | YICHANG HUMANWELL |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 211200 | ZHEJIANG JUTAI PHARM |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 201567 | ZYDUS PHARMS |
| WELLBUTRIN XL | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB3 | 021515 | BAUSCH |
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