Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021015
Company: BESINS HLTHCARE
Company: BESINS HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ANDROGEL | TESTOSTERONE | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL;TRANSDERMAL | Discontinued | None | Yes | No |
| ANDROGEL | TESTOSTERONE | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL;TRANSDERMAL | Discontinued | None | Yes | No |
| ANDROGEL | TESTOSTERONE | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED;TRANSDERMAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 02/28/2000 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-015_AndroGel.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/30/2019 | SUPPL-46 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021015Orig1s046ltr.pdf |
| 05/10/2019 | SUPPL-45 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021015s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021015Orig1s045ltr.pdf | |
| 02/25/2019 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021015s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021015Orig1s044ltr.pdf | |
| 10/25/2016 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021015s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021015Orig1s043ltr.pdf | |
| 08/17/2015 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/2015 | SUPPL-40 | Labeling-Medication Guide, Labeling-Package Insert, REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021015s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021015Orig1s040ltr.pdf | |
| 06/19/2014 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021015s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021015Orig1s039ltr.pdf | |
| 11/12/2014 | SUPPL-38 | Labeling-Package Insert, REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021015Orig1s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021015Orig1s038ltr.pdf | |
| 02/27/2014 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/2013 | SUPPL-36 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021015s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021015Orig1s036ltr.pdf | |
| 09/20/2012 | SUPPL-34 | Labeling, Labeling-Container/Carton Labels, REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021015Orig1s034lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021015Orig1s034ltr.pdf | |
| 11/19/2012 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/2011 | SUPPL-32 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021015s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021015s032ltr.pdf | |
| 03/10/2011 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021015s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021015s028ltr.pdf | |
| 09/18/2009 | SUPPL-22 | Labeling, REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021015s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021015s022ltr.pdf | |
| 03/19/2009 | SUPPL-21 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/27/2007 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021015s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021015s019,s020ltr.pdf | |
| 12/27/2007 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021015s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021015s019,s020ltr.pdf | |
| 12/13/2007 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021015s016ltr.pdf | |
| 07/14/2006 | SUPPL-14 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 08/16/2005 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021015s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021015s013ltr.pdf | |
| 11/19/2004 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21015s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21015s012ltr.pdf | |
| 08/11/2005 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021015s011ltr.pdf |
| 09/26/2003 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21015scp010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021015_s010_AndrogelTOC.cfm |
| 09/17/2003 | SUPPL-8 | Labeling |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21015slr008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021015_s008_AndrogelTOC.cfm |
| 09/18/2002 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/09/2001 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/27/2001 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 10/22/2002 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21015s4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21015slr004ltr.pdf | |
| 09/05/2001 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 01/23/2001 | SUPPL-2 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/07/2000 | 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 |
|---|---|---|---|---|---|
| 05/10/2019 | SUPPL-45 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021015s045lbl.pdf | |
| 02/25/2019 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021015s044lbl.pdf | |
| 10/25/2016 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021015s043lbl.pdf | |
| 05/11/2015 | SUPPL-40 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021015s040lbl.pdf | |
| 05/11/2015 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021015s040lbl.pdf | |
| 05/11/2015 | SUPPL-40 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021015s040lbl.pdf | |
| 11/12/2014 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021015Orig1s038lbl.pdf | |
| 11/12/2014 | SUPPL-38 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021015Orig1s038lbl.pdf | |
| 06/19/2014 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021015s039lbl.pdf | |
| 05/20/2013 | SUPPL-36 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021015s036lbl.pdf | |
| 05/20/2013 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021015s036lbl.pdf | |
| 09/20/2012 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021015Orig1s034lbledt.pdf | |
| 09/20/2012 | SUPPL-34 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021015Orig1s034lbledt.pdf | |
| 09/20/2012 | SUPPL-34 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021015Orig1s034lbledt.pdf | |
| 11/30/2011 | SUPPL-32 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021015s032lbl.pdf | |
| 03/10/2011 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021015s028lbl.pdf | |
| 09/18/2009 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021015s022lbl.pdf | |
| 09/18/2009 | SUPPL-22 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021015s022lbl.pdf | |
| 12/27/2007 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021015s019s020lbl.pdf | |
| 12/27/2007 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021015s019s020lbl.pdf | |
| 12/13/2007 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021015s016lbl.pdf | |
| 08/16/2005 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021015s013lbl.pdf | |
| 11/19/2004 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21015s012lbl.pdf | |
| 10/22/2002 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21015s4lbl.pdf | |
| 02/28/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21015lbl.pdf |