Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018644
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
WELLBUTRIN BUPROPION HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
WELLBUTRIN BUPROPION HYDROCHLORIDE 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
WELLBUTRIN BUPROPION HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
12/30/1985 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018644Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/11/2017 SUPPL-53 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018644s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018644Orig1s053,020358Orig1s060ltr.pdf
05/04/2017 SUPPL-52 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018644s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018644Orig1s052,020358Orig1s059ltr.pdf
05/10/2017 SUPPL-51 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018644s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018644Orig1s051,020358Orig1s058ltr.pdf
04/25/2016 SUPPL-50 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-49 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018644s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018644Orig1s049,020358Orig1s056ltr.pdf
12/16/2014 SUPPL-48 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-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018644s046s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018644Orig1s046,s047;020358Orig1s053,s054ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/018644Orig1s047.pdf
12/23/2013 SUPPL-46 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018644s046s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018644Orig1s046,s047;020358Orig1s053,s054ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/018644Orig1s046.pdf
03/19/2013 SUPPL-45 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-44 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-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018644s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018644s043,020358s050ltr.pdf
05/17/2011 SUPPL-42 Labeling-Package Insert, Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018644s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018644s042,020358s039,s049ltr.pdf
02/26/2010 SUPPL-41 Labeling, REMS-Proposal 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-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018644s039s040.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018644s039,018644s040,020358s046,020358s047ltr.pdf
07/01/2009 SUPPL-39 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018644s039s040.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018644s039,018644s040,020358s046,020358s047ltr.pdf
05/25/2010 SUPPL-38 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-36 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018644s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018644s036, 020358s043, 021515s020, 020711s029ltr.pdf
01/29/2007 SUPPL-35 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018644s035, 20358s042ltr.pdf
07/03/2006 SUPPL-34 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/2006/018644Orig1s034.pdf
07/03/2006 SUPPL-33 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-31 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-30 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-28 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
10/22/2002 SUPPL-26 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644slr026,20358slr029ltr.pdf
02/13/2002 SUPPL-25 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644s25ltr.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
06/20/2002 SUPPL-22 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644slr024,20358slr024ltr.pdf
04/10/2000 SUPPL-21 Labeling

Label is not available on this site.

04/10/2000 SUPPL-20 Labeling

Label is not available on this site.

04/10/2000 SUPPL-19 Labeling

Label is not available on this site.

04/10/2000 SUPPL-18 Labeling

Label is not available on this site.

04/10/2000 SUPPL-17 Labeling

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.

10/31/1996 SUPPL-13 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018644a_s010_s012_s013.pdf
11/27/1995 SUPPL-12 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018644a_s010_s012_s013.pdf
11/27/1995 SUPPL-10 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018644a_s010_s012_s013.pdf
06/24/1991 SUPPL-8 Labeling

Label is not available on this site.

03/23/1994 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/23/1994 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

03/23/1994 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/24/1991 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/30/1989 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

02/11/1986 SUPPL-2 Labeling

Label is not available on this site.

02/11/1986 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/11/2017 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018644s053lbl.pdf
05/10/2017 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018644s051lbl.pdf
05/10/2017 SUPPL-51 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018644s051lbl.pdf
05/04/2017 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018644s052lbl.pdf
04/25/2016 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018644s050,020358s057lbl.pdf
12/16/2014 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018644s048,020358s055lbl.pdf
07/17/2014 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018644s049lbl.pdf
12/23/2013 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018644s046s047lbl.pdf
12/23/2013 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018644s046s047lbl.pdf
03/19/2013 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018644s045,020358s052lbl.pdf
03/19/2013 SUPPL-45 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018644s045,020358s052lbl.pdf
07/25/2011 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018644s043lbl.pdf
05/17/2011 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018644s042lbl.pdf
05/17/2011 SUPPL-42 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018644s042lbl.pdf
05/25/2010 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018644s038,020358s045lbl.pdf
07/01/2009 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018644s039s040.pdf
07/01/2009 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018644s039s040.pdf
08/02/2007 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018644s036lbl.pdf
07/03/2006 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018644s33s34,020358s37s40,021515s14lbl.pdf
07/03/2006 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018644s33s34,020358s37s40,021515s14lbl.pdf
01/12/2005 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18644s030,20358s034,21515s009,20711s021lbl.pdf

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