Orange Book product · Generic (ANDA)
SAFINAMIDE MESYLATE
SAFINAMIDE MESYLATE
Generic (ANDA)ANDA 215913TE ABRX ZENARA
At a glance
Jun 13, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 13, 2025
1 yr ago
Today
Pharmaceutical detail
Active ingredient
SAFINAMIDE MESYLATE
Strength
EQ 50MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 215913
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of SAFINAMIDE MESYLATE
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.
