Orange Book product · Generic (ANDA)
TESTOSTERONE ENANTHATE
TESTOSTERONE ENANTHATE
At a glance
Feb 28, 2024
Approved
Generic (ANDA)
Application
AO
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 28, 2024
2 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
TESTOSTERONE ENANTHATE
Strength
200MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AO
Application
ANDA 212659
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of TESTOSTERONE ENANTHATE
- 2018XYOSTED (AUTOINJECTOR)Brand (NDA)
NDA 209863 · ANTARES PHARMA INC
- —DELATESTRYLBrand (NDA)
NDA 009165 · ENDO PHARMS
- 2012TESTOSTERONE ENANTHATEGeneric (ANDA)
ANDA 091120 · HIKMA FARMACEUTICA
- 2009TESTOSTERONE ENANTHATEGeneric (ANDA)
ANDA 040647 · RISING
- 2006TESTOSTERONE ENANTHATEGeneric (ANDA)
ANDA 040575 · NEXUS
- —TESTOSTERONE ENANTHATEGeneric (ANDA)
ANDA 083667 · WATSON LABS
- —TESTOSTERONE ENANTHATEGeneric (ANDA)
ANDA 085599 · WATSON LABS
- —TESTOSTERONE ENANTHATEGeneric (ANDA)
ANDA 085598 · WATSON PHARMS INC
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.
