Orange Book product · Generic (ANDA)
TESTOSTERONE
TESTOSTERONE
At a glance
Aug 05, 2015
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 05, 2015
11 yr ago
Today
Pharmaceutical detail
Active ingredient
TESTOSTERONE
Strength
10MG/0.5GM ACTUATION
Dosage form
GEL, METERED
Route
TRANSDERMAL
TE code
Not listed
Application
ANDA 204571
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of TESTOSTERONE
- 2014VOGELXOBrand (NDA)
NDA 204399 · UPSHER SMITH LABS
- 2014NATESTOBrand (NDA)
NDA 205488 · ACERUS
- 2013TESTOSTERONEBrand (NDA)
NDA 203098 · PERRIGO ISRAEL
- 2012TESTOSTERONEBrand (NDA)
NDA 202763 · ANI PHARMS
- 2011ANDRODERMBrand (NDA)
NDA 020489 · ABBVIE
- 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
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.
