Home Applications 205435 Application 205435
Type NDA
Sponsor CUBIST PHARMS LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SIVEXTRO TEDIZOLID PHOSPHATE TABLET;ORAL 200MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205435-001 SIVEXTRO TEDIZOLID PHOSPHATE 200MG TABLET / ORAL RLD, RS 2014-06-20
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205435-001 8420676 2028-02-23 U-282 Drug substance, Drug product 2014-07-03 N205435-001 7816379 2028-06-20 U-2507 Drug substance, Drug product 2014-07-03 N205435-001 10065947 2030-02-03 Drug product 2019-04-09 N205435-001 10442829 2030-02-03 Drug substance 2019-11-13 N205435-001 9624250 2030-02-03 U-2507 Drug substance, Drug product 2019-04-09 N205435-001 9988406 2030-02-03 Drug product 2019-04-09 N205435-001 8426389 2030-12-31 U-282 Drug substance, Drug product 2014-07-03
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N205435-001 NPP 2028-04-04
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 · 43 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 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205435-001 SIVEXTRO 200MG TABLET / ORAL RLD, RS 2014-06-20 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 8 · 298 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 N205435-001 8420676 2028-02-23 U-282 Drug substance, Drug product 2014-07-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205435-001 7816379 2028-06-20 U-2507 Drug substance, Drug product 2014-07-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205435-001 10065947 2030-02-03 Drug product 2019-04-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205435-001 10442829 2030-02-03 Drug substance 2019-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205435-001 9624250 2030-02-03 U-2507 Drug substance, Drug product 2019-04-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205435-001 9988406 2030-02-03 Drug product 2019-04-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205435-001 8426389 2030-12-31 U-282 Drug substance, Drug product 2014-07-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N205435-001 8420676 2028-02-23 U-282 Drug substance, Drug product 2014-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205435-001 7816379 2028-06-20 U-2507 Drug substance, Drug product 2014-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205435-001 10065947 2030-02-03 Drug product 2019-04-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205435-001 10442829 2030-02-03 Drug substance 2019-11-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205435-001 9624250 2030-02-03 U-2507 Drug substance, Drug product 2019-04-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205435-001 9988406 2030-02-03 Drug product 2019-04-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205435-001 8426389 2030-12-31 U-282 Drug substance, Drug product 2014-07-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205435-001 8420676 2028-02-23 U-282 Drug substance, Drug product 2014-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205435-001 7816379 2028-06-20 U-2507 Drug substance, Drug product 2014-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205435-001 10065947 2030-02-03 Drug product 2019-04-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205435-001 10442829 2030-02-03 Drug substance 2019-11-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205435-001 9624250 2030-02-03 U-2507 Drug substance, Drug product 2019-04-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205435-001 9988406 2030-02-03 Drug product 2019-04-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205435-001 8426389 2030-12-31 U-282 Drug substance, Drug product 2014-07-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205435-001 8420676 2028-02-23 U-282 Drug substance, Drug product 2014-07-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205435-001 7816379 2028-06-20 U-2507 Drug substance, Drug product 2014-07-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205435-001 10065947 2030-02-03 Drug product 2019-04-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205435-001 10442829 2030-02-03 Drug substance 2019-11-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205435-001 9624250 2030-02-03 U-2507 Drug substance, Drug product 2019-04-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205435-001 9988406 2030-02-03 Drug product 2019-04-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205435-001 8426389 2030-12-31 U-282 Drug substance, Drug product 2014-07-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205435-001 8420676 2028-02-23 U-282 Drug substance, Drug product 2014-07-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205435-001 7816379 2028-06-20 U-2507 Drug substance, Drug product 2014-07-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205435-001 10065947 2030-02-03 Drug product 2019-04-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205435-001 10442829 2030-02-03 Drug substance 2019-11-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205435-001 9624250 2030-02-03 U-2507 Drug substance, Drug product 2019-04-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205435-001 9988406 2030-02-03 Drug product 2019-04-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205435-001 8426389 2030-12-31 U-282 Drug substance, Drug product 2014-07-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205435-001 8420676 2028-02-23 U-282 Drug substance, Drug product 2014-07-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205435-001 7816379 2028-06-20 U-2507 Drug substance, Drug product 2014-07-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205435-001 10065947 2030-02-03 Drug product 2019-04-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205435-001 10442829 2030-02-03 Drug substance 2019-11-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205435-001 9624250 2030-02-03 U-2507 Drug substance, Drug product 2019-04-09 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 96 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 15 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 67919-041 SIVEXTRO tedizolid phosphate Merck Sharp & Dohme Corp. NDA Current 67919-041 SIVEXTRO tedizolid phosphate Merck Sharp & Dohme Corp. NDA Current 67919-041 SIVEXTRO tedizolid phosphate Merck Sharp & Dohme Corp. NDA Current 67919-041 SIVEXTRO tedizolid phosphate Merck Sharp & Dohme LLC NDA Current 67919-041 SIVEXTRO tedizolid phosphate Merck Sharp & Dohme LLC NDA Current 67919-041 SIVEXTRO tedizolid phosphate Merck Sharp & Dohme LLC NDA Current 67919-041 SIVEXTRO tedizolid phosphate Merck Sharp & Dohme Corp. NDA Current 67919-041 SIVEXTRO tedizolid phosphate Merck Sharp & Dohme Corp. NDA Current 67919-041 SIVEXTRO tedizolid phosphate Merck Sharp & Dohme Corp. NDA Current 72000-310 SIVEXTRO tedizolid phosphate Nabriva Therapeutics US, Inc. NDA Current 72000-310 SIVEXTRO tedizolid phosphate Nabriva Therapeutics US, Inc. NDA Current 72000-310 SIVEXTRO tedizolid phosphate Nabriva Therapeutics US, Inc. NDA Current 72000-310 SIVEXTRO tedizolid phosphate Nabriva Therapeutics US, Inc. NDA Current 72000-310 SIVEXTRO tedizolid phosphate Nabriva Therapeutics US, Inc. NDA Current 72000-310 SIVEXTRO tedizolid phosphate Nabriva Therapeutics US, Inc. NDA Current