Orange Book product · Brand (NDA)
NATESTO
TESTOSTERONE
At a glance
May 28, 2014
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 28, 2014
12 yr 3 mo ago
Today
Patent 11090312 expires
Listed method-of-use patent (U-1616) expiration.
Mar 17, 2034
in 7 yr 10 mo
Patent 11744838 expires
Listed method-of-use patent (U-4366) expiration.
Mar 17, 2034
in 7 yr 10 mo
Patent 11744838 expires
Listed method-of-use patent (U-4367) expiration.
Mar 17, 2034
in 7 yr 10 mo
Pharmaceutical detail
Active ingredient
TESTOSTERONE
Strength
5.5MG/0.122GM ACTUATION
Dosage form
GEL, METERED
Route
NASAL
TE code
Not listed
Application
NDA 205488
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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
- 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
- 1993TESTODERMBrand (NDA)
NDA 019762 · ALZA
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11090312 | Mar 17, 2034 | in 7 yr 10 mo | U-1616 |
| 11744838 | Mar 17, 2034 | in 7 yr 10 mo | U-4366 |
| 11744838 | Mar 17, 2034 | in 7 yr 10 mo | U-4367 |
