Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021463
Company: ENDO PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FORTESTA TESTOSTERONE 10MG/0.5GM 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
12/29/2010 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/2010/021463s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021463s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021463_fortesta_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021463Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/30/2019 SUPPL-21 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021463Orig1s021ltr.pdf
05/10/2019 SUPPL-20 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021463s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021463Orig1s020ltr.pdf
10/25/2016 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021463s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021463Orig1s019ltr.pdf
03/10/2016 SUPPL-18 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021463s018lbl.pdf
05/11/2015 SUPPL-17 Labeling-Package Insert, REMS-Modified, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021463s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021463Orig1s017ltr.pdf
07/31/2014 SUPPL-15 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021463Orig1s015ltr.pdf
06/19/2014 SUPPL-14 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021463s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021463Orig1s014ltr.pdf
06/04/2014 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/24/2014 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021463s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021463Orig1s012ltr.pdf
11/26/2013 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/11/2013 SUPPL-10 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021463s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021463Orig1s010ltr.pdf
09/09/2013 SUPPL-9 Manufacturing (CMC)

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-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021463s020lbl.pdf
05/10/2019 SUPPL-20 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021463s020lbl.pdf
10/25/2016 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021463s019lbl.pdf
03/10/2016 SUPPL-18 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021463s018lbl.pdf
05/11/2015 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021463s017lbl.pdf
05/11/2015 SUPPL-17 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021463s017lbl.pdf
05/11/2015 SUPPL-17 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021463s017lbl.pdf
06/19/2014 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021463s014lbl.pdf
06/19/2014 SUPPL-14 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021463s014lbl.pdf
03/24/2014 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021463s012lbl.pdf
09/11/2013 SUPPL-10 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021463s010lbl.pdf
12/29/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021463s000lbl.pdf

FORTESTA

GEL, METERED;TRANSDERMAL; 10MG/0.5GM ACTUATION
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FORTESTA TESTOSTERONE 10MG/0.5GM ACTUATION GEL, METERED;TRANSDERMAL Prescription Yes AB 021463 ENDO PHARMS
TESTOSTERONE TESTOSTERONE 10MG/0.5GM ACTUATION GEL, METERED;TRANSDERMAL Prescription No AB 204571 ACTAVIS LABS UT INC

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