Home Applications 206316 Application 206316
Type NDA
Sponsor DAIICHI SANKYO INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SAVAYSA EDOXABAN TOSYLATE TABLET;ORAL EQ 15MG BASE Yes No 002 SAVAYSA EDOXABAN TOSYLATE TABLET;ORAL EQ 30MG BASE Yes No 003 SAVAYSA EDOXABAN TOSYLATE TABLET;ORAL EQ 60MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N206316-001 SAVAYSA EDOXABAN TOSYLATE EQ 15MG BASE TABLET / ORAL RLD 2015-01-08 N206316-002 SAVAYSA EDOXABAN TOSYLATE EQ 30MG BASE TABLET / ORAL RLD 2015-01-08 N206316-003 SAVAYSA EDOXABAN TOSYLATE EQ 60MG BASE TABLET / ORAL RLD, RS 2015-01-08
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 N206316-001 7365205 2027-04-18 Drug substance 2015-01-30 N206316-001 9149532 2028-03-28 Drug product 2015-12-17 N206316-002 7365205 2027-04-18 Drug substance 2015-01-30 N206316-002 9149532 2028-03-28 Drug product 2015-12-17 N206316-003 7365205 2027-04-18 Drug substance 2015-01-30 N206316-003 9149532 2028-03-28 Drug product 2015-12-17
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N206316-001 M-14 2026-10-18 N206316-002 M-14 2026-10-18 N206316-003 M-14 2026-10-18
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 4 · 129 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 N206316-001 SAVAYSA EQ 15MG BASE TABLET / ORAL RLD 2015-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206316-002 SAVAYSA EQ 30MG BASE TABLET / ORAL RLD 2015-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206316-003 SAVAYSA EQ 60MG BASE TABLET / ORAL RLD, RS 2015-01-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 N206316-001 SAVAYSA EQ 15MG BASE TABLET / ORAL RLD 2015-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206316-002 SAVAYSA EQ 30MG BASE TABLET / ORAL RLD 2015-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206316-003 SAVAYSA EQ 60MG BASE TABLET / ORAL RLD, RS 2015-01-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206316-001 SAVAYSA EQ 15MG BASE TABLET / ORAL RLD 2015-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206316-002 SAVAYSA EQ 30MG BASE TABLET / ORAL RLD 2015-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206316-003 SAVAYSA EQ 60MG BASE TABLET / ORAL RLD, RS 2015-01-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206316-001 SAVAYSA EQ 15MG BASE TABLET / ORAL RLD 2015-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206316-002 SAVAYSA EQ 30MG BASE TABLET / ORAL RLD 2015-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206316-003 SAVAYSA EQ 60MG BASE TABLET / ORAL RLD, RS 2015-01-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206316-001 SAVAYSA EQ 15MG BASE TABLET / ORAL RLD 2015-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206316-002 SAVAYSA EQ 30MG BASE TABLET / ORAL RLD 2015-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206316-003 SAVAYSA EQ 60MG BASE TABLET / ORAL RLD, RS 2015-01-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206316-001 SAVAYSA EQ 15MG BASE TABLET / ORAL RLD 2015-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206316-002 SAVAYSA EQ 30MG BASE TABLET / ORAL RLD 2015-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206316-003 SAVAYSA EQ 60MG BASE TABLET / ORAL RLD, RS 2015-01-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206316-001 SAVAYSA EQ 15MG BASE TABLET / ORAL RLD 2015-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206316-002 SAVAYSA EQ 30MG BASE TABLET / ORAL RLD 2015-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206316-003 SAVAYSA EQ 60MG BASE TABLET / ORAL RLD, RS 2015-01-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206316-001 SAVAYSA EQ 15MG BASE TABLET / ORAL RLD 2015-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206316-002 SAVAYSA EQ 30MG BASE TABLET / ORAL RLD 2015-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206316-003 SAVAYSA EQ 60MG BASE TABLET / ORAL RLD, RS 2015-01-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206316-001 SAVAYSA EQ 15MG BASE TABLET / ORAL RLD 2015-01-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206316-002 SAVAYSA EQ 30MG BASE TABLET / ORAL RLD 2015-01-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206316-003 SAVAYSA EQ 60MG BASE TABLET / ORAL RLD, RS 2015-01-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206316-001 SAVAYSA EQ 15MG BASE TABLET / ORAL RLD 2015-01-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206316-002 SAVAYSA EQ 30MG BASE TABLET / ORAL RLD 2015-01-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206316-003 SAVAYSA EQ 60MG BASE TABLET / ORAL RLD, RS 2015-01-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206316-001 SAVAYSA EQ 15MG BASE TABLET / ORAL RLD 2015-01-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206316-002 SAVAYSA EQ 30MG BASE TABLET / ORAL RLD 2015-01-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206316-003 SAVAYSA EQ 60MG BASE TABLET / ORAL RLD, RS 2015-01-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206316-001 SAVAYSA EQ 15MG BASE TABLET / ORAL RLD 2015-01-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206316-002 SAVAYSA EQ 30MG BASE TABLET / ORAL RLD 2015-01-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206316-003 SAVAYSA EQ 60MG BASE TABLET / ORAL RLD, RS 2015-01-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206316-001 SAVAYSA EQ 15MG BASE TABLET / ORAL RLD 2015-01-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206316-002 SAVAYSA EQ 30MG BASE TABLET / ORAL RLD 2015-01-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206316-003 SAVAYSA EQ 60MG BASE TABLET / ORAL RLD, RS 2015-01-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206316-001 SAVAYSA EQ 15MG BASE TABLET / ORAL RLD 2015-01-08 301d65b070ca…
Observed Orange Book patent history# Patent history page 1 of 7 · 258 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N206316-001 7365205 2027-04-18 Drug substance 2015-01-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206316-001 9149532 2028-03-28 Drug product 2015-12-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206316-002 7365205 2027-04-18 Drug substance 2015-01-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206316-002 9149532 2028-03-28 Drug product 2015-12-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206316-003 7365205 2027-04-18 Drug substance 2015-01-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206316-003 9149532 2028-03-28 Drug product 2015-12-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N206316-001 7365205 2027-04-18 Drug substance 2015-01-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206316-001 9149532 2028-03-28 Drug product 2015-12-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206316-002 7365205 2027-04-18 Drug substance 2015-01-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206316-002 9149532 2028-03-28 Drug product 2015-12-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206316-003 7365205 2027-04-18 Drug substance 2015-01-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206316-003 9149532 2028-03-28 Drug product 2015-12-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206316-001 7365205 2027-04-18 Drug substance 2015-01-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206316-001 9149532 2028-03-28 Drug product 2015-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206316-002 7365205 2027-04-18 Drug substance 2015-01-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206316-002 9149532 2028-03-28 Drug product 2015-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206316-003 7365205 2027-04-18 Drug substance 2015-01-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206316-003 9149532 2028-03-28 Drug product 2015-12-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206316-001 7365205 2027-04-18 Drug substance 2015-01-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206316-001 9149532 2028-03-28 Drug product 2015-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206316-002 7365205 2027-04-18 Drug substance 2015-01-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206316-002 9149532 2028-03-28 Drug product 2015-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206316-003 7365205 2027-04-18 Drug substance 2015-01-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206316-003 9149532 2028-03-28 Drug product 2015-12-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206316-001 7365205 2027-04-18 Drug substance 2015-01-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206316-001 9149532 2028-03-28 Drug product 2015-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206316-002 7365205 2027-04-18 Drug substance 2015-01-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206316-002 9149532 2028-03-28 Drug product 2015-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206316-003 7365205 2027-04-18 Drug substance 2015-01-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206316-003 9149532 2028-03-28 Drug product 2015-12-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206316-001 7365205 2027-04-18 Drug substance 2015-01-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206316-001 9149532 2028-03-28 Drug product 2015-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206316-002 7365205 2027-04-18 Drug substance 2015-01-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206316-002 9149532 2028-03-28 Drug product 2015-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206316-003 7365205 2027-04-18 Drug substance 2015-01-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206316-003 9149532 2028-03-28 Drug product 2015-12-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206316-001 7365205 2027-04-18 Drug substance 2015-01-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206316-001 9149532 2028-03-28 Drug product 2015-12-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206316-002 7365205 2027-04-18 Drug substance 2015-01-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206316-002 9149532 2028-03-28 Drug product 2015-12-17 b8a1b40f171c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 126 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 65597-201 SAVAYSA EDOXABAN TOSYLATE Daiichi Sankyo Inc. NDA Current 65597-201 SAVAYSA EDOXABAN TOSYLATE Daiichi Sankyo Inc. NDA Current 65597-201 SAVAYSA EDOXABAN TOSYLATE Daiichi Sankyo Inc. NDA Current 65597-201 SAVAYSA EDOXABAN TOSYLATE Daiichi Sankyo Inc. NDA Current 65597-201 SAVAYSA EDOXABAN TOSYLATE Daiichi Sankyo NDA Current 65597-201 SAVAYSA EDOXABAN TOSYLATE Daiichi Sankyo Inc. NDA Current 65597-202 SAVAYSA EDOXABAN TOSYLATE Daiichi Sankyo Inc. NDA Current 65597-202 SAVAYSA EDOXABAN TOSYLATE Daiichi Sankyo Inc. NDA Current 65597-202 SAVAYSA EDOXABAN TOSYLATE Daiichi Sankyo Inc. NDA Current 65597-202 SAVAYSA EDOXABAN TOSYLATE Daiichi Sankyo Inc. NDA Current 65597-202 SAVAYSA EDOXABAN TOSYLATE Daiichi Sankyo NDA Current 65597-202 SAVAYSA EDOXABAN TOSYLATE Daiichi Sankyo Inc. NDA Current 65597-203 SAVAYSA EDOXABAN TOSYLATE Daiichi Sankyo Inc. NDA Current 65597-203 SAVAYSA EDOXABAN TOSYLATE Daiichi Sankyo Inc. NDA Current 65597-203 SAVAYSA EDOXABAN TOSYLATE Daiichi Sankyo Inc. NDA Current 65597-203 SAVAYSA EDOXABAN TOSYLATE Daiichi Sankyo Inc. NDA Current 65597-203 SAVAYSA EDOXABAN TOSYLATE Daiichi Sankyo NDA Current 65597-203 SAVAYSA EDOXABAN TOSYLATE Daiichi Sankyo Inc. NDA Current