Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022309
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANDROGEL TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED;TRANSDERMAL Prescription AB Yes Yes
ANDROGEL TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL;TRANSDERMAL Prescription AB2 Yes No
ANDROGEL TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL;TRANSDERMAL Prescription AB2 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
04/29/2011 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022309s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022309s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022309_androgel_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022309Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/25/2016 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022309s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022309Orig1s017ltr.pdf
08/17/2015 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/11/2015 SUPPL-14 Labeling-Medication Guide, Labeling-Package Insert, REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022309s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022309Orig1s014ltr.pdf
06/11/2015 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/19/2014 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022309s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022309Orig1s012ltr.pdf
11/14/2014 SUPPL-11 Labeling-Package Insert, REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022309s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022309Orig1s011ltr.pdf
02/28/2014 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/20/2013 SUPPL-8 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022309s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022309Orig1s008ltr.pdf
03/12/2013 SUPPL-7 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022309Orig1s007ltr.pdf
03/13/2013 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/19/2012 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/07/2012 SUPPL-1 Labeling-Container/Carton Labels, REMS-Modified Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022309s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022309Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022309Orig1s001.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/25/2016 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022309s017lbl.pdf
05/11/2015 SUPPL-14 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022309s014lbl.pdf
05/11/2015 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022309s014lbl.pdf
05/11/2015 SUPPL-14 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022309s014lbl.pdf
11/14/2014 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022309s011lbl.pdf
11/14/2014 SUPPL-11 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022309s011lbl.pdf
06/19/2014 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022309s012lbl.pdf
05/20/2013 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022309s008lbl.pdf
05/20/2013 SUPPL-8 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022309s008lbl.pdf
09/07/2012 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022309s001lbl.pdf
09/07/2012 SUPPL-1 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022309s001lbl.pdf
04/29/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022309s000lbl.pdf

ANDROGEL

GEL, METERED;TRANSDERMAL; 1.62% (20.25MG/1.25GM ACTUATION)
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANDROGEL TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED;TRANSDERMAL Prescription Yes AB 022309 ABBVIE
TESTOSTERONE TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED;TRANSDERMAL Prescription No AB 204268 PERRIGO ISRAEL

GEL;TRANSDERMAL; 1.62% (20.25MG/1.25GM PACKET)
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANDROGEL TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL;TRANSDERMAL Prescription Yes AB2 022309 ABBVIE
TESTOSTERONE TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL;TRANSDERMAL Prescription No AB2 205781 PERRIGO UK FINCO

GEL;TRANSDERMAL; 1.62% (40.5MG/2.5GM PACKET)
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANDROGEL TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL;TRANSDERMAL Prescription Yes AB2 022309 ABBVIE
TESTOSTERONE TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL;TRANSDERMAL Prescription No AB2 205781 PERRIGO UK FINCO

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