Orange Book product · Generic (ANDA)
APREMILAST
APREMILAST
At a glance
Jul 19, 2023
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 19, 2023
3 yr ago
Today
Pharmaceutical detail
Active ingredient
APREMILAST
Strength
10MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 211716
Product number
001
Marketing status
DISCN
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.
