Home Applications 215902 Application 215902
Type ANDA
Sponsor AUROBINDO PHARMA 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 A215902-001 SAFINAMIDE MESYLATE SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL 2023-06-14 A215902-002 SAFINAMIDE MESYLATE SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL 2023-06-14
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.
Product history page 1 of 2 · 46 observed 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 A215902-001 SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL 2023-06-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215902-002 SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL 2023-06-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215902-001 SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL 2023-06-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215902-002 SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL 2023-06-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215902-001 SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL 2023-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215902-002 SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL 2023-06-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215902-001 SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL 2023-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215902-002 SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL 2023-06-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215902-001 SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL 2023-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215902-002 SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL 2023-06-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215902-001 SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL 2023-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215902-002 SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL 2023-06-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215902-001 SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL 2023-06-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215902-002 SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL 2023-06-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215902-001 SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL 2023-06-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215902-002 SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL 2023-06-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215902-001 SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL 2023-06-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215902-002 SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL 2023-06-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215902-001 SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL 2023-06-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215902-002 SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL 2023-06-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215902-001 SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL 2023-06-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215902-002 SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL 2023-06-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215902-001 SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL 2023-06-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215902-002 SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL 2023-06-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215902-001 SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL 2023-06-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215902-002 SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL 2023-06-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215902-001 SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL 2023-06-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215902-002 SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL 2023-06-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215902-001 SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL 2023-06-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215902-002 SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL 2023-06-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215902-001 SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL 2023-06-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A215902-002 SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL 2023-06-14 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215902-001 SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL 2023-06-14 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215902-002 SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL 2023-06-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215902-001 SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL 2023-06-14 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A215902-002 SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL 2023-06-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215902-001 SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL 2023-06-14 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A215902-002 SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL 2023-06-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215902-001 SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL 2023-06-14 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215902-002 SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL 2023-06-14 a72a2bbeb626…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 74741 ORIG 2023-07-13