Orange Book product · Generic (ANDA)
DROSPIRENONE AND ESTRADIOL
DROSPIRENONE; ESTRADIOL
Generic (ANDA)ANDA 218031TE ABRX NOVAST LABS
At a glance
Oct 28, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 28, 2025
8 mo ago
Today
Pharmaceutical detail
Active ingredient
DROSPIRENONE; ESTRADIOL
Strength
0.5MG;1MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 218031
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DROSPIRENONE; ESTRADIOL
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.
