Orange Book product · Generic (ANDA)
ESTRADIOL VALERATE
ESTRADIOL VALERATE
At a glance
Apr 28, 2023
Approved
Generic (ANDA)
Application
AO
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 28, 2023
3 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
ESTRADIOL VALERATE
Strength
10MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AO
Application
ANDA 216656
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ESTRADIOL VALERATE
- —DELESTROGENBrand (NDA)
NDA 009402 · PH HEALTH
- 2020ESTRADIOL VALERATEGeneric (ANDA)
ANDA 203723 · HIKMA
- 2010ESTRADIOL VALERATEGeneric (ANDA)
ANDA 090920 · AM REGENT
- 2007ESTRADIOL VALERATEGeneric (ANDA)
ANDA 040628 · FOSUN PHARMA
- —ESTRADIOL VALERATEGeneric (ANDA)
ANDA 083547 · DR REDDYS
- —ESTRADIOL VALERATEGeneric (ANDA)
ANDA 083714 · DR REDDYS
- —ESTRADIOL VALERATEGeneric (ANDA)
ANDA 083546 · WATSON LABS
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.
