Home Applications 203585 Application 203585
Type NDA
Sponsor TEVA PHARMS INTL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SYNRIBO OMACETAXINE MEPESUCCINATE POWDER;SUBCUTANEOUS 3.5MG/VIAL Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N203585-001 SYNRIBO OMACETAXINE MEPESUCCINATE 3.5MG/VIAL POWDER / SUBCUTANEOUS RLD 2012-10-26
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N203585-001 6987103 2026-10-26 U-1300 2012-11-20
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 2 of 2 · 44 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 2022-10-28 04:53 UTC 2022-10 N203585-001 SYNRIBO 3.5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-10-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N203585-001 SYNRIBO 3.5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-10-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N203585-001 SYNRIBO 3.5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2012-10-26 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N203585-001 SYNRIBO 3.5MG/VIAL POWDER / SUBCUTANEOUS RLD 2012-10-26 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 48 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 c2088c7a36db…2026-09-14 22:38:34 2026-08 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203585-001 RE45128 2019-03-16 U-1576 Drug substance, Drug product 2014-09-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203585-001 RE45128 2019-03-16 U-1576 Drug substance, Drug product 2014-09-26 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203585-001 RE45128 2019-03-16 U-1576 Drug substance, Drug product 2014-09-26 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203585-001 RE45128 2019-03-16 U-1576 Drug substance, Drug product 2014-09-26 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203585-001 6987103 2026-10-26 U-1300 2012-11-20 a67488948f0b…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2019-12-13 00:20 UTC 2019-12 N203585-001 ODE-32 2019-10-26 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N203585-001 ODE-32 2019-10-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203585-001 ODE-32 2019-10-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203585-001 ODE-32 2019-10-26 ea99ee380514…
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 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 63459-177 SYNRIBO Omacetaxine Mepesuccinate Cephalon, Inc. NDA Current 63459-177 SYNRIBO Omacetaxine Mepesuccinate Cephalon, Inc. NDA Current 63459-177 SYNRIBO Omacetaxine Mepesuccinate Cephalon, Inc. NDA Current 63459-177 SYNRIBO Omacetaxine Mepesuccinate Cephalon, Inc. NDA Current 63459-177 SYNRIBO Omacetaxine Mepesuccinate Cephalon, Inc. NDA Current 63459-177 SYNRIBO Omacetaxine Mepesuccinate Cephalon, LLC NDA Current 63459-177 SYNRIBO Omacetaxine Mepesuccinate Cephalon, Inc. NDA Current