Orange Book product · Brand (NDA)
FEMTRACE
ESTRADIOL ACETATE
Brand (NDA)NDA 021633DISCN APIL
At a glance
Aug 20, 2004
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 20, 2004
22 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
ESTRADIOL ACETATE
Strength
0.45MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 021633
Product number
001
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.
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.
