Orange Book product · Brand (NDA)
ANDRODERM
TESTOSTERONE
At a glance
Oct 20, 2011
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 20, 2011
14 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
TESTOSTERONE
Strength
2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
FILM, EXTENDED RELEASE
Route
TRANSDERMAL
TE code
Not listed
Application
NDA 020489
Product number
003
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2014VOGELXOBrand (NDA)
NDA 204399 · UPSHER SMITH LABS
- 2014NATESTOBrand (NDA)
NDA 205488 · ACERUS
- 2013TESTOSTERONEBrand (NDA)
NDA 203098 · PERRIGO ISRAEL
- 2012TESTOSTERONEBrand (NDA)
NDA 202763 · ANI PHARMS
- 2011ANDROGELBrand (NDA)
NDA 022309 · BESINS HLTHCARE
- 2010FORTESTABrand (NDA)
NDA 021463 · ENDO OPERATIONS
- 2010AXIRONBrand (NDA)
NDA 022504 · ELI LILLY AND CO
- 2003ANDROGELBrand (NDA)
NDA 021015 · BESINS HLTHCARE
- 2003STRIANTBrand (NDA)
NDA 021543 · AUXILIUM PHARMS LLC
- 2002TESTIMBrand (NDA)
NDA 021454 · ENDO OPERATIONS
- 1997TESTODERM TTSBrand (NDA)
NDA 020791 · ALZA
- 1993TESTODERMBrand (NDA)
NDA 019762 · ALZA
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
