Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020489
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ANDRODERM | TESTOSTERONE | 2.5MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
| ANDRODERM | TESTOSTERONE | 5MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
| ANDRODERM | TESTOSTERONE | 2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | Yes | No |
| ANDRODERM | TESTOSTERONE | 4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 09/29/1995 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/11/2020 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020489s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020489Orig1s036ltr.pdf | |
| 10/25/2016 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020489s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020489Orig1s034ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020489Orig1s034.pdf | |
| 05/11/2015 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020489s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020489Orig1s033ltr.pdf | |
| 04/30/2015 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/19/2014 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020489s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020489Orig1s031ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/020489Orig1s031.pdf | |
| 01/16/2014 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/2012 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020489s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020489Orig1s027ltr.pdf | |
| 10/20/2011 | SUPPL-25 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020489s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020489s025ltr.pdf | |
| 05/19/2006 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020489s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020489s013LTR.pdf | |
| 11/27/2002 | SUPPL-11 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/09/2002 | SUPPL-10 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20489slr010ltr.pdf |
| 10/24/2000 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/13/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/15/2002 | SUPPL-7 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20489s7ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020489_S007_ANDRODERM_AP.pdf |
| 10/09/1998 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/29/1998 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/18/1998 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 05/02/1997 | SUPPL-3 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20489-S003_ANDRODERM.PDF |
| 04/22/1997 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/10/1996 | 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 |
|---|---|---|---|---|---|
| 05/11/2020 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020489s036lbl.pdf | |
| 10/25/2016 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020489s034lbl.pdf | |
| 05/11/2015 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020489s033lbl.pdf | |
| 06/19/2014 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020489s031lbl.pdf | |
| 04/26/2012 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020489s027lbl.pdf | |
| 10/20/2011 | SUPPL-25 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020489s025lbl.pdf | |
| 05/19/2006 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020489s013lbl.pdf |