Home Applications 207145 Application 207145
Type NDA
Sponsor US WORLDMEDS LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 XADAGO SAFINAMIDE MESYLATE TABLET;ORAL 50MG Yes No 002 XADAGO SAFINAMIDE MESYLATE TABLET;ORAL 100MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N207145-001 XADAGO SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 N207145-002 XADAGO SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N207145-001 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 N207145-001 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 N207145-001 8283380 2031-03-21 U-1993 2017-04-20 N207145-002 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 N207145-002 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 N207145-002 8283380 2031-03-21 U-1993 2017-04-20
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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL RLD 2017-03-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL RLD, RS 2017-03-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL RLD 2017-03-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL RLD, RS 2017-03-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL RLD 2017-03-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL RLD, RS 2017-03-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207145-001 XADAGO 50MG TABLET / ORAL RLD 2017-03-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N207145-002 XADAGO 100MG TABLET / ORAL RLD, RS 2017-03-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL RLD 2017-03-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL RLD, RS 2017-03-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL RLD 2017-03-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL RLD, RS 2017-03-21 782e0a99824c…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 7 · 246 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N207145-001 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207145-001 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207145-001 8283380 2031-03-21 U-1993 2017-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207145-002 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207145-002 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207145-002 8283380 2031-03-21 U-1993 2017-04-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207145-001 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207145-001 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207145-001 8283380 2031-03-21 U-1993 2017-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207145-002 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207145-002 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207145-002 8283380 2031-03-21 U-1993 2017-04-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207145-001 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207145-001 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207145-001 8283380 2031-03-21 U-1993 2017-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207145-002 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207145-002 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207145-002 8283380 2031-03-21 U-1993 2017-04-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207145-001 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207145-001 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207145-001 8283380 2031-03-21 U-1993 2017-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207145-002 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207145-002 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207145-002 8283380 2031-03-21 U-1993 2017-04-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207145-001 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207145-001 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207145-001 8283380 2031-03-21 U-1993 2017-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207145-002 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207145-002 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207145-002 8283380 2031-03-21 U-1993 2017-04-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207145-001 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207145-001 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207145-001 8283380 2031-03-21 U-1993 2017-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207145-002 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207145-002 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207145-002 8283380 2031-03-21 U-1993 2017-04-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207145-001 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207145-001 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207145-001 8283380 2031-03-21 U-1993 2017-04-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207145-002 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 2680178bc6a6…
Observed Orange Book exclusivity history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Xadago SAFINAMIDE MESYLATE MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. c4d65f28-983f-42b4-bb23-023ae0fe81b2 2025-10-22 Warnings, Adverse reactions Exact identifier application applno (NDA): 207145 application number: NDA207145 ndc (product): 27505-110 ndc (product): 27505-111
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 18 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 27505-110 Xadago safinamide mesylate US WorldMeds, LLC NDA Current 27505-110 Xadago safinamide mesylate US WorldMeds, LLC NDA Current 27505-110 Xadago safinamide mesylate MDD US Operations, LLC NDA Current 27505-110 Xadago safinamide mesylate US WorldMeds, LLC NDA Current 27505-110 Xadago safinamide mesylate MDD US Operations, LLC NDA Current 27505-110 Xadago safinamide mesylate MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. NDA Current 27505-110 Xadago safinamide mesylate MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. NDA Current 27505-110 Xadago safinamide mesylate MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. NDA Current 27505-110 Xadago safinamide mesylate US WorldMeds, LLC NDA Current 27505-111 Xadago safinamide mesylate US WorldMeds, LLC NDA Current 27505-111 Xadago safinamide mesylate US WorldMeds, LLC NDA Current 27505-111 Xadago safinamide mesylate MDD US Operations, LLC NDA Current 27505-111 Xadago safinamide mesylate US WorldMeds, LLC NDA Current 27505-111 Xadago safinamide mesylate MDD US Operations, LLC NDA Current 27505-111 Xadago safinamide mesylate MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. NDA Current 27505-111 Xadago safinamide mesylate MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. NDA Current 27505-111 Xadago safinamide mesylate MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. NDA Current 27505-111 Xadago safinamide mesylate US WorldMeds, LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 68325 SUPPL 2021-08-10 68316 SUPPL 2021-08-09 61100 SUPPL 2019-11-29 61081 SUPPL 2019-11-27 48775 SUPPL 2017-06-20 48756 SUPPL 2017-06-19 48180 ORIG 2017-05-01 47730 ORIG 2017-03-28 47630 ORIG 2017-03-22