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FDA NDA · NDA020489

ANDRODERM

Sponsor: ABBVIE

APPLICATION
NDA020489
TYPE
NDA
ORIGINAL APPROVAL
1995-09-29
LATEST ACTION
2020-05-11
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

ANDRODERM · ReferenceDiscontinued
TESTOSTERONE 4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FILM, EXTENDED RELEASE · TRANSDERMAL
ANDRODERMDiscontinued
TESTOSTERONE 5MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
ANDRODERM · ReferenceDiscontinued
TESTOSTERONE 2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FILM, EXTENDED RELEASE · TRANSDERMAL
ANDRODERMDiscontinued
TESTOSTERONE 2.5MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL

Approval history

2020-05-11Labeling · Supplement 36 · standard — Label ↗AP
2016-10-25Labeling · Supplement 34 · standard — Letter ↗AP
2015-05-11Labeling · Supplement 33 · standard — Label ↗AP
2015-04-30Manufacturing (CMC) · Supplement 32 · standardAP
2014-06-19Labeling · Supplement 31 · standard — Review ↗AP
2014-01-16Manufacturing (CMC) · Supplement 30 · standardAP
2012-04-26Labeling · Supplement 27 · standard — Letter ↗AP
2011-10-20Efficacy · Supplement 25 · standard — Label ↗AP
2006-05-19Labeling · Supplement 13 · standard — Letter ↗AP
2002-11-27Manufacturing (CMC) · Supplement 11 · standardAP
2002-08-09Labeling · Supplement 10 · standard — Letter ↗AP
2002-01-15Labeling · Supplement 7 · standard — Review ↗AP
2000-10-24Manufacturing (CMC) · Supplement 9 · standardAP
2000-07-13Manufacturing (CMC) · Supplement 8 · standardAP
1998-10-09Manufacturing (CMC) · Supplement 6 · standardAP
1998-06-29Manufacturing (CMC) · Supplement 5 · standardAP
1998-03-18Labeling · Supplement 4 · standardAP
1997-05-02Manufacturing (CMC) · Supplement 3 · standard — Review ↗AP
1997-04-22Manufacturing (CMC) · Supplement 2 · standardAP
1996-07-10Labeling · Supplement 1 · standardAP
1995-09-29Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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