Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021015
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANDROGEL TESTOSTERONE 25MG/2.5GM PACKET GEL;TRANSDERMAL Prescription AB1 Yes No
ANDROGEL TESTOSTERONE 50MG/5GM PACKET GEL;TRANSDERMAL Prescription AB1 Yes Yes
ANDROGEL TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED;TRANSDERMAL Prescription AB 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
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
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-Container/Carton Labels, Labeling, 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 REMS-Proposal, Labeling 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-Package Insert, Labeling-Container/Carton Labels

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
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-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021015Orig1s034lbledt.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 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 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021015s022lbl.pdf
09/18/2009 SUPPL-22 Labeling 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

ANDROGEL

GEL;TRANSDERMAL; 25MG/2.5GM PACKET
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANDROGEL TESTOSTERONE 25MG/2.5GM PACKET GEL;TRANSDERMAL Prescription Yes AB1 021015 ABBVIE
TESTOSTERONE TESTOSTERONE 25MG/2.5GM PACKET GEL;TRANSDERMAL Prescription No AB1 076737 ACTAVIS LABS UT INC
TESTOSTERONE TESTOSTERONE 25MG/2.5GM PACKET GEL;TRANSDERMAL Prescription No AB1 076744 PAR PHARM
TESTOSTERONE TESTOSTERONE 25MG/2.5GM PACKET GEL;TRANSDERMAL Prescription No AB1 203098 PERRIGO ISRAEL

GEL;TRANSDERMAL; 50MG/5GM PACKET
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANDROGEL TESTOSTERONE 50MG/5GM PACKET GEL;TRANSDERMAL Prescription Yes AB1 021015 ABBVIE
TESTOSTERONE TESTOSTERONE 50MG/5GM PACKET GEL;TRANSDERMAL Prescription No AB1 076737 ACTAVIS LABS UT INC
TESTOSTERONE TESTOSTERONE 50MG/5GM PACKET GEL;TRANSDERMAL Prescription No AB1 076744 PAR PHARM
TESTOSTERONE TESTOSTERONE 50MG/5GM PACKET GEL;TRANSDERMAL Prescription No AB1 203098 PERRIGO ISRAEL

GEL, METERED;TRANSDERMAL; 12.5MG/1.25GM ACTUATION
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANDROGEL TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED;TRANSDERMAL Prescription Yes AB 021015 ABBVIE
TESTOSTERONE TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED;TRANSDERMAL Prescription No AB 076737 ACTAVIS LABS UT INC
TESTOSTERONE TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED;TRANSDERMAL Prescription No AB 203098 PERRIGO ISRAEL

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English