Orange Book product · Generic (ANDA)
EPOPROSTENOL SODIUM
EPOPROSTENOL SODIUM
Generic (ANDA)ANDA 213913TE AP2RX MYLAN
At a glance
Jun 12, 2024
Approved
Generic (ANDA)
Application
AP2
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 12, 2024
2 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
EPOPROSTENOL SODIUM
Strength
EQ 0.5MG BASE/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP2
Application
ANDA 213913
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of EPOPROSTENOL SODIUM
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.
