Orange Book product · Generic (ANDA)
OSPEMIFENE
OSPEMIFENE
Generic (ANDA)ANDA 215574DISCN HETERO LABS LTD V
At a glance
Feb 13, 2024
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 13, 2024
2 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
OSPEMIFENE
Strength
60MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 215574
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of OSPEMIFENE
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.
