Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020358
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| WELLBUTRIN SR | BUPROPION HYDROCHLORIDE | 50MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| WELLBUTRIN SR | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB1 | Yes | No |
| WELLBUTRIN SR | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB1 | Yes | No |
| WELLBUTRIN SR | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB1 | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 10/04/1996 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/07/2024 | SUPPL-68 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020358s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/018644Orig1s061;020358Orig1s068ltr.pdf | |
| 12/06/2022 | SUPPL-66 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020358s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018644Orig1s059;020358Orig1s066ltr.pdf | |
| 10/20/2020 | SUPPL-64 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020358s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018644Orig1s057,020358Orig1s064ltr.pdf | |
| 11/05/2019 | SUPPL-61 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020358s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018644Orig1s054, 020358Orig1s061ltr.pdf | |
| 08/11/2017 | SUPPL-60 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020358s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018644Orig1s053,020358Orig1s060ltr.pdf | |
| 05/04/2017 | SUPPL-59 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020358s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018644Orig1s052,020358Orig1s059ltr.pdf | |
| 05/10/2017 | SUPPL-58 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020358s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018644Orig1s051,020358Orig1s058ltr.pdf | |
| 04/25/2016 | SUPPL-57 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018644s050,020358s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018644Orig1s050,020358Orig1s057ltr.pdf | |
| 07/17/2014 | SUPPL-56 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020358s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018644Orig1s049,020358Orig1s056ltr.pdf | |
| 12/16/2014 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018644s048,020358s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018644Orig1s048,020358Orig1s055ltr.pdf | |
| 12/23/2013 | SUPPL-54 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020358s053s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018644Orig1s046,s047;020358Orig1s053,s054ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020358Orig1s054.pdf | |
| 12/23/2013 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020358s053s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018644Orig1s046,s047;020358Orig1s053,s054ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020358Orig1s053.pdf | |
| 03/19/2013 | SUPPL-52 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018644s045,020358s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018644Orig1s045,020358Origs052ltr.pdf | |
| 08/02/2012 | SUPPL-51 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018644Orig1s044,020358Orig1s051ltr.pdf |
| 07/25/2011 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020358s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018644s043,020358s050ltr.pdf | |
| 05/17/2011 | SUPPL-49 | Labeling, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020358s039s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018644s042,020358s039,s049ltr.pdf | |
| 02/26/2010 | SUPPL-48 | REMS-Proposal, Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018644s041,020358s048ltr.pdf |
| 07/01/2009 | SUPPL-47 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020358s046s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018644s039,018644s040,020358s046,020358s047ltr.pdf | |
| 07/01/2009 | SUPPL-46 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020358s046s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018644s039,018644s040,020358s046,020358s047ltr.pdf | |
| 05/25/2010 | SUPPL-45 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018644s038,020358s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018644s038,020358s045ltr.pdf | |
| 08/02/2007 | SUPPL-43 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020358s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018644s036, 020358s043, 021515s020, 020711s029ltr.pdf | |
| 01/29/2007 | SUPPL-42 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018644s035,020358s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018644s035, 20358s042ltr.pdf | |
| 07/03/2006 | SUPPL-40 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018644s33s34,020358s37s40,021515s14lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018644s33,018644s34,020358s37,020358s40,021515s14LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020358Orig1s040.pdf | |
| 05/17/2011 | SUPPL-39 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020358s039s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018644s042,020358s039,s049ltr.pdf | |
| 07/03/2006 | SUPPL-37 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018644s33s34,020358s37s40,021515s14lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018644s33,018644s34,020358s37,020358s40,021515s14LTR.pdf | |
| 02/28/2006 | SUPPL-35 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021515s012_020358s035_018644s031ltr.pdf |
| 01/12/2005 | SUPPL-34 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18644s030,20358s034,21515s009,20711s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18644s030,20358s034,21515s009,20711s021ltr.pdf | |
| 05/27/2004 | SUPPL-32 | Labeling |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18644slr028,20358slr032,21515slr007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018644s027s028,020358s031s032,021515s006s007_WellbutrinTOC.cfm |
| 04/26/2004 | SUPPL-30 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20358slr030ltr.pdf |
| 10/22/2002 | SUPPL-29 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644slr026,20358slr029ltr.pdf |
| 07/12/2002 | SUPPL-28 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20358scm028ltr.pdf |
| 06/14/2002 | SUPPL-27 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20358s27lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20358s027ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020358_S027_WELLBUTRIN_TABS_AP.pdf | |
| 07/12/2002 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/13/2002 | SUPPL-25 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020358Orig1s025.pdf |
| 10/02/2002 | SUPPL-24 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644slr024,20358slr024ltr.pdf |
| 06/20/2002 | SUPPL-23 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644s022,023and20358s018,023LTR.pdf |
| 10/11/2000 | SUPPL-22 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020358Orig1s020_s021_s022.pdf |
| 10/11/2000 | SUPPL-21 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020358Orig1s020_s021_s022.pdf |
| 10/11/2000 | SUPPL-20 | Manufacturing (CMC)-Formulation |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020358Orig1s020_s021_s022.pdf |
| 06/11/2001 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20358s19lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20358s19ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-358S019_Bupropion.pdf | |
| 06/20/2002 | SUPPL-18 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644slr024,20358slr024ltr.pdf |
| 08/04/2000 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/10/2000 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 04/10/2000 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 04/10/2000 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 04/10/2000 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 04/10/2000 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 04/06/1999 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/1999 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/06/1999 | SUPPL-9 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/10/2000 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/10/2000 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 11/30/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/1998 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/30/1998 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/16/1997 | SUPPL-3 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020358a_s001_s003.pdf |
| 01/26/1999 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 12/16/1997 | SUPPL-1 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020358a_s001_s003.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/07/2024 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020358s068lbl.pdf | |
| 12/06/2022 | SUPPL-66 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020358s066lbl.pdf | |
| 10/20/2020 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020358s064lbl.pdf | |
| 11/05/2019 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020358s061lbl.pdf | |
| 08/11/2017 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020358s060lbl.pdf | |
| 05/10/2017 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020358s058lbl.pdf | |
| 05/10/2017 | SUPPL-58 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020358s058lbl.pdf | |
| 05/04/2017 | SUPPL-59 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020358s059lbl.pdf | |
| 04/25/2016 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018644s050,020358s057lbl.pdf | |
| 12/16/2014 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018644s048,020358s055lbl.pdf | |
| 07/17/2014 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020358s056lbl.pdf | |
| 12/23/2013 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020358s053s054lbl.pdf | |
| 12/23/2013 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020358s053s054lbl.pdf | |
| 03/19/2013 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018644s045,020358s052lbl.pdf | |
| 03/19/2013 | SUPPL-52 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018644s045,020358s052lbl.pdf | |
| 07/25/2011 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020358s050lbl.pdf | |
| 05/17/2011 | SUPPL-49 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020358s039s049lbl.pdf | |
| 05/17/2011 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020358s039s049lbl.pdf | |
| 05/17/2011 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020358s039s049lbl.pdf | |
| 05/25/2010 | SUPPL-45 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018644s038,020358s045lbl.pdf | |
| 07/01/2009 | SUPPL-47 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020358s046s047lbl.pdf | |
| 07/01/2009 | SUPPL-46 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020358s046s047lbl.pdf | |
| 08/02/2007 | SUPPL-43 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020358s043lbl.pdf | |
| 01/29/2007 | SUPPL-42 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018644s035,020358s042lbl.pdf | |
| 07/03/2006 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018644s33s34,020358s37s40,021515s14lbl.pdf | |
| 07/03/2006 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018644s33s34,020358s37s40,021515s14lbl.pdf | |
| 01/12/2005 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18644s030,20358s034,21515s009,20711s021lbl.pdf | |
| 06/14/2002 | SUPPL-27 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20358s27lbl.pdf |
| 06/11/2001 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20358s19lbl.pdf |
WELLBUTRIN SR
TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 079095 | ACTAVIS LABS FL INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 216800 | ANNORA PHARMA |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 075932 | EPIC PHARMA LLC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 075913 | IMPAX LABS |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 202304 | PRINSTON INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 205794 | SCIEGEN PHARMS INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 211347 | YICHANG HUMANWELL |
| WELLBUTRIN SR | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB1 | 020358 | GLAXOSMITHKLINE |
TABLET, EXTENDED RELEASE;ORAL; 150MG
TE Code = AB1
| 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 | AB1 | 079095 | ACTAVIS LABS FL INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 216800 | ANNORA PHARMA |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 075932 | EPIC PHARMA LLC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 075913 | IMPAX LABS |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 202304 | PRINSTON INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 205794 | SCIEGEN PHARMS INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 211347 | YICHANG HUMANWELL |
| WELLBUTRIN SR | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB1 | 020358 | GLAXOSMITHKLINE |
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 | 216800 | ANNORA PHARMA |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 075932 | EPIC PHARMA LLC |
| 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 | 205794 | SCIEGEN PHARMS INC |
| 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 |