Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021515
Company: BAUSCH
Company: BAUSCH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| WELLBUTRIN XL | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB3 | Yes | No |
| WELLBUTRIN XL | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB3 | 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 |
|---|---|---|---|---|---|---|---|
| 08/28/2003 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21515_wellbutrin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21515ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021515_Wellbutrin.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/04/2022 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021515s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021515Orig1s044; 022108Orig1s022Corrected_ltr.pdf | |
| 07/08/2021 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021515s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021515Orig1s043; 022108Orig1s021ltr.pdf | |
| 11/05/2019 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021515s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021515Orig1s040ltr.pdf | |
| 05/04/2017 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021515s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021515Orig1s036,022108Orig1s014ltr.pdf | |
| 08/30/2016 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021515s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021515Orig1s034ltr.pdf | |
| 05/24/2016 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/2014 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021515s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021515Orig1s032ltr.pdf | |
| 11/21/2014 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/30/2014 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021515s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021515Orig1s029,s030,022108Orig1s009ltr.pdf | |
| 12/30/2014 | SUPPL-29 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021515s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021515Orig1s029,s030,022108Orig1s009ltr.pdf | |
| 08/02/2012 | SUPPL-28 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021515Orig1s028ltr.pdf |
| 07/26/2011 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021515s026s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021515s026,s027,022108s005,s006ltr.pdf | |
| 07/26/2011 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021515s026s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021515s026,s027,022108s005,s006ltr.pdf | |
| 02/26/2010 | SUPPL-25 | REMS-Proposal, Labeling |
Label is not available on this site. |
||
| 07/01/2009 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021515s023s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021515s023,02515s024ltr.pdf | |
| 07/01/2009 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021515s023s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021515s023,02515s024ltr.pdf | |
| 05/25/2010 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021515s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021515s022ltr.pdf | |
| 08/02/2007 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021515s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018644s036, 020358s043, 021515s020, 020711s029ltr.pdf | |
| 06/12/2006 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021515s010s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021515s010,021515s018LTR.pdf | |
| 07/03/2006 | SUPPL-14 | 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-12 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021515s012_020358s035_018644s031ltr.pdf |
| 06/12/2006 | SUPPL-10 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021515s010s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021515s010,021515s018LTR.pdf | |
| 01/12/2005 | SUPPL-9 | 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-7 | 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 |
| 10/28/2004 | SUPPL-2 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21515s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/04/2022 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021515s044lbl.pdf | |
| 07/08/2021 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021515s043lbl.pdf | |
| 11/05/2019 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021515s040lbl.pdf | |
| 05/04/2017 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021515s036lbl.pdf | |
| 08/30/2016 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021515s034lbl.pdf | |
| 12/30/2014 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021515s029s030lbl.pdf | |
| 12/30/2014 | SUPPL-29 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021515s029s030lbl.pdf | |
| 12/30/2014 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021515s029s030lbl.pdf | |
| 07/11/2014 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021515s032lbl.pdf | |
| 07/26/2011 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021515s026s027lbl.pdf | |
| 07/26/2011 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021515s026s027lbl.pdf | |
| 05/25/2010 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021515s022lbl.pdf | |
| 07/01/2009 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021515s023s024lbl.pdf | |
| 07/01/2009 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021515s023s024lbl.pdf | |
| 08/02/2007 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021515s020lbl.pdf | |
| 07/03/2006 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018644s33s34,020358s37s40,021515s14lbl.pdf | |
| 06/12/2006 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021515s010s018lbl.pdf | |
| 06/12/2006 | SUPPL-10 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021515s010s018lbl.pdf | |
| 01/12/2005 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18644s030,20358s034,21515s009,20711s021lbl.pdf | |
| 08/28/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21515_wellbutrin_lbl.pdf |
WELLBUTRIN XL
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 | 207224 | ANBISON LAB |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 215568 | GRANULES |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 211020 | GRAVITI 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 |
TABLET, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB3
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 210497 | ACCORD HLTHCARE |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 207224 | ANBISON LAB |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 215568 | GRANULES |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 211020 | GRAVITI PHARMS |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 090693 | LUPIN LTD |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 207479 | SCIEGEN PHARMS INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 208652 | SINOTHERAPEUTICS INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 203650 | SUN PHARM |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 210081 | TWI PHARMS |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 077285 | WATSON LABS INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 202189 | WOCKHARDT LTD |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 210015 | YICHANG HUMANWELL |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 211200 | ZHEJIANG JUTAI PHARM |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 201567 | ZYDUS PHARMS |
| WELLBUTRIN XL | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB3 | 021515 | BAUSCH |