Home Applications 211192 Application 211192
Type NDA
Sponsor AGIOS PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TIBSOVO IVOSIDENIB TABLET;ORAL 250MG 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 N211192-001 TIBSOVO IVOSIDENIB 250MG TABLET / ORAL RLD, RS 2018-07-20
Orange Book patents# Current patent rows page 1 of 1 · 31 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211192-001 10610125 2030-06-21 U-2784 2020-04-28 N211192-001 10610125 2030-06-21 U-2785 2020-04-28 N211192-001 10610125 2030-06-21 U-3385 2020-04-28 N211192-001 10717764 2033-01-18 U-3215 2021-09-24 N211192-001 11667673 2033-01-18 U-3742 2023-11-17 N211192-001 9850277 2033-01-18 U-2350 Drug substance, Drug product 2018-08-13 N211192-001 9850277 2033-01-18 U-2533 Drug substance, Drug product 2018-08-13 N211192-001 9850277 2033-01-18 U-2534 Drug substance, Drug product 2018-08-13 N211192-001 9850277 2033-01-18 U-3213 Drug substance, Drug product 2018-08-13 N211192-001 9850277 2033-01-18 U-3386 Drug substance, Drug product 2018-08-13 N211192-001 9850277 2033-01-18 U-3742 Drug substance, Drug product 2018-08-13 N211192-001 9474779 2033-08-19 U-2350 Drug substance, Drug product 2018-08-13 N211192-001 9474779 2033-08-19 U-2533 Drug substance, Drug product 2018-08-13 N211192-001 9474779 2033-08-19 U-2534 Drug substance, Drug product 2018-08-13 N211192-001 9474779 2033-08-19 U-3213 Drug substance, Drug product 2018-08-13 N211192-001 9474779 2033-08-19 U-3386 Drug substance, Drug product 2018-08-13 N211192-001 9474779 2033-08-19 U-3742 Drug substance, Drug product 2018-08-13 N211192-001 10449184 2035-03-13 Drug product 2019-11-12 N211192-001 10799490 2035-03-13 U-2981 Drug product 2020-11-06 N211192-001 10799490 2035-03-13 U-2982 Drug product 2020-11-06 N211192-001 10799490 2035-03-13 U-3384 Drug product 2020-11-06 N211192-001 9968595 2035-03-13 U-2351 Drug product 2018-08-13 N211192-001 9968595 2035-03-13 U-2533 Drug product 2018-08-13 N211192-001 9968595 2035-03-13 U-2534 Drug product 2018-08-13 N211192-001 9968595 2035-03-13 U-3384 Drug product 2018-08-13 N211192-001 10653710 2036-10-18 U-3387 2022-06-23 N211192-001 10980788 2039-06-07 U-3112 2021-05-20 N211192-001 10980788 2039-06-07 U-3113 2021-05-20 N211192-001 10980788 2039-06-07 U-3214 2021-05-20 N211192-001 10980788 2039-06-07 U-3383 2021-05-20 N211192-001 10980788 2039-06-07 U-3743 2021-05-20
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 matching rows.
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 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211192-001 TIBSOVO 250MG TABLET / ORAL RLD, RS 2018-07-20 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 28 · 1,082 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 N211192-001 10610125 2030-06-21 U-2784 2020-04-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 10610125 2030-06-21 U-2785 2020-04-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 10610125 2030-06-21 U-3385 2020-04-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 10717764 2033-01-18 U-3215 2021-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 11667673 2033-01-18 U-3742 2023-11-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9850277 2033-01-18 U-2534 Drug substance, Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9850277 2033-01-18 U-2350 Drug substance, Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9850277 2033-01-18 U-2533 Drug substance, Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9850277 2033-01-18 U-3742 Drug substance, Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9850277 2033-01-18 U-3386 Drug substance, Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9850277 2033-01-18 U-3213 Drug substance, Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9474779 2033-08-19 U-2534 Drug substance, Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9474779 2033-08-19 U-2533 Drug substance, Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9474779 2033-08-19 U-2350 Drug substance, Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9474779 2033-08-19 U-3742 Drug substance, Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9474779 2033-08-19 U-3386 Drug substance, Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9474779 2033-08-19 U-3213 Drug substance, Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 10449184 2035-03-13 Drug product 2019-11-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 10799490 2035-03-13 U-3384 Drug product 2020-11-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 10799490 2035-03-13 U-2981 Drug product 2020-11-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 10799490 2035-03-13 U-2982 Drug product 2020-11-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9968595 2035-03-13 U-2534 Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9968595 2035-03-13 U-2533 Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9968595 2035-03-13 U-2351 Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 9968595 2035-03-13 U-3384 Drug product 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 10653710 2036-10-18 U-3387 2022-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 10980788 2039-06-07 U-3214 2021-05-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 10980788 2039-06-07 U-3743 2021-05-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 10980788 2039-06-07 U-3383 2021-05-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 10980788 2039-06-07 U-3112 2021-05-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211192-001 10980788 2039-06-07 U-3113 2021-05-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211192-001 10610125 2030-06-21 U-2784 2020-04-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211192-001 10610125 2030-06-21 U-2785 2020-04-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211192-001 10610125 2030-06-21 U-3385 2020-04-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211192-001 10717764 2033-01-18 U-3215 2021-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211192-001 11667673 2033-01-18 U-3742 2023-11-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211192-001 9850277 2033-01-18 U-2534 Drug substance, Drug product 2018-08-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211192-001 9850277 2033-01-18 U-2350 Drug substance, Drug product 2018-08-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211192-001 9850277 2033-01-18 U-2533 Drug substance, Drug product 2018-08-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211192-001 9850277 2033-01-18 U-3742 Drug substance, Drug product 2018-08-13 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 7 · 247 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TIBSOVO IVOSIDENIB Servier Pharmaceutical LLC 65d254c0-67ad-42c4-b972-ad463b755b2d 2025-12-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 211192 application number: NDA211192 ndc (product): 72694-617
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 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 71334-100 Tibsovo ivosidenib Agios Pharmaceuticals, Inc. NDA Current 71334-100 Tibsovo ivosidenib Agios Pharmaceuticals, Inc. NDA Current 71334-100 Tibsovo ivosidenib Agios Pharmaceuticals, Inc. NDA Current 71334-100 Tibsovo ivosidenib Agios Pharmaceuticals, Inc. NDA Current 71334-100 Tibsovo ivosidenib Agios Pharmaceuticals, Inc. NDA Current 71334-100 Tibsovo ivosidenib Agios Pharmaceuticals, Inc. NDA Current 71334-100 Tibsovo ivosidenib Agios Pharmaceuticals, Inc. NDA Current 72694-617 TIBSOVO ivosidenib Servier Pharmaceutical LLC NDA Current 72694-617 TIBSOVO ivosidenib Servier Pharmaceutical LLC NDA Current 72694-617 Tibsovo ivosidenib Servier Pharmaceuticals LLC NDA Current