Home Applications 215913 Application 215913
Type ANDA
Sponsor ZENARA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SAFINAMIDE MESYLATE SAFINAMIDE MESYLATE TABLET;ORAL EQ 50MG BASE No No 002 SAFINAMIDE MESYLATE SAFINAMIDE MESYLATE TABLET;ORAL EQ 100MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215913-001 SAFINAMIDE MESYLATE SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL AB 2025-06-13 A215913-002 SAFINAMIDE MESYLATE SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL AB 2025-06-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A215913-001 SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL AB 2025-06-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215913-002 SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL AB 2025-06-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215913-001 SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL AB 2025-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215913-002 SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL AB 2025-06-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215913-001 SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL AB 2025-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215913-002 SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL AB 2025-06-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215913-001 SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL AB 2025-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215913-002 SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL AB 2025-06-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215913-001 SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL AB 2025-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215913-002 SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL AB 2025-06-13 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215913-001 SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL AB 2025-06-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215913-002 SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL AB 2025-06-13 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.