Orange Book product · Brand (NDA)
DELESTROGEN
ESTRADIOL VALERATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AO
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
ESTRADIOL VALERATE
Strength
10MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AO
Application
NDA 009402
Product number
002
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.
- 2023ESTRADIOL VALERATEGeneric (ANDA)
ANDA 216656 · XIROMED
- 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.
