Orange Book product · Generic (ANDA)
APREMILAST
APREMILAST
At a glance
Jul 26, 2023
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 26, 2023
2 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
APREMILAST
Strength
10MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 211878
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
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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.
