Orange Book product · Brand (NDA)
DELATESTRYL
TESTOSTERONE ENANTHATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
TESTOSTERONE ENANTHATE
Strength
200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 009165
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.
- 2018XYOSTED (AUTOINJECTOR)Brand (NDA)
NDA 209863 · ANTARES PHARMA INC
- 2024TESTOSTERONE ENANTHATEGeneric (ANDA)
ANDA 212659 · EUGIA PHARMA
- 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.
