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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020489
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ANDRODERM TESTOSTERONE 2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None Yes No
ANDRODERM TESTOSTERONE 4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None Yes No

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
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