Orange Book product · Brand (NDA)
ANDROGEL
TESTOSTERONE
At a glance
Feb 28, 2000
Approved
Brand (NDA)
Application
AB1
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 28, 2000
26 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
TESTOSTERONE
Strength
50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
GEL
Route
TRANSDERMAL
TE code
AB1
Application
NDA 021015
Product number
002
Marketing status
RX
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
- 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
- 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.
