Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021463
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FORTESTA | TESTOSTERONE | 10MG/0.5GM ACTUATION | 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 |
---|---|---|---|---|---|---|---|
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 |
---|---|---|---|---|---|
06/30/2020 | SUPPL-25 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021463s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021463Orig1s025ltr.pdf | |
03/13/2020 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021463s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021463Orig1s022ltr.pdf | |
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-Medication Guide, Labeling-Package Insert |
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-Medication Guide, Labeling-Package Insert, REMS-Modified |
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-Medication Guide, Labeling-Package Insert |
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 |
---|---|---|---|---|---|
06/30/2020 | SUPPL-25 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021463s025lbl.pdf | |
03/13/2020 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021463s022lbl.pdf | |
05/10/2019 | SUPPL-20 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021463s020lbl.pdf | |
05/10/2019 | SUPPL-20 | Labeling-Package Insert | 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-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021463s017lbl.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 | |
06/19/2014 | SUPPL-14 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021463s014lbl.pdf | |
06/19/2014 | SUPPL-14 | Labeling-Package Insert | 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 |