Home Applications 205266 Application 205266
Type NDA
Sponsor SUN PHARMA GLOBAL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ODOMZO SONIDEGIB PHOSPHATE CAPSULE;ORAL EQ 200MG BASE 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 N205266-001 ODOMZO SONIDEGIB PHOSPHATE EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205266-001 8178563 2029-07-24 U-1722 Drug substance 2015-08-18 N205266-001 8063043 2029-09-15 Drug substance, Drug product 2015-08-18 N205266-001 10266523 2036-03-30 Drug substance, Drug product 2022-05-18
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 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 2026-10-15 13:18:30 2026-09 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 c2088c7a36db…2026-09-14 22:38:34 2026-08 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205266-001 ODOMZO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2015-07-24 3a93d1ddd44b…
Observed Orange Book patent history# Patent history page 2 of 3 · 120 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205266-001 8063043 2029-09-15 Drug substance, Drug product 2015-08-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205266-001 10266523 2036-03-30 Drug substance, Drug product 2022-05-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205266-001 8178563 2029-07-24 U-1722 Drug substance 2015-08-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205266-001 8063043 2029-09-15 Drug substance, Drug product 2015-08-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205266-001 10266523 2036-03-30 Drug substance, Drug product 2022-05-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205266-001 8178563 2029-07-24 U-1722 Drug substance 2015-08-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205266-001 8063043 2029-09-15 Drug substance, Drug product 2015-08-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205266-001 10266523 2036-03-30 Drug substance, Drug product 2022-05-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205266-001 8178563 2029-07-24 U-1722 Drug substance 2015-08-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N205266-001 8063043 2029-09-15 Drug substance, Drug product 2015-08-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N205266-001 10266523 2036-03-30 Drug substance, Drug product 2022-05-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205266-001 8178563 2029-07-24 U-1722 Drug substance 2015-08-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205266-001 8063043 2029-09-15 Drug substance, Drug product 2015-08-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205266-001 10266523 2036-03-30 Drug substance, Drug product 2022-05-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205266-001 8178563 2029-07-24 U-1722 Drug substance 2015-08-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N205266-001 8063043 2029-09-15 Drug substance, Drug product 2015-08-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205266-001 8178563 2029-07-24 U-1722 Drug substance 2015-08-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N205266-001 8063043 2029-09-15 Drug substance, Drug product 2015-08-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205266-001 8178563 2029-02-06 U-1722 Drug substance 2015-08-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N205266-001 8063043 2029-09-15 Drug substance, Drug product 2015-08-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205266-001 8178563 2029-07-24 U-1722 Drug substance 2015-08-18 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N205266-001 8063043 2029-09-15 Drug substance, Drug product 2015-08-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205266-001 8178563 2029-07-24 U-1722 Drug substance 2015-08-18 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N205266-001 8063043 2029-09-15 Drug substance, Drug product 2015-08-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205266-001 8178563 2029-07-24 U-1722 Drug substance 2015-08-18 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205266-001 8063043 2029-09-15 Drug substance, Drug product 2015-08-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205266-001 8178563 2029-07-24 U-1722 Drug substance 2015-08-18 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N205266-001 8063043 2029-09-15 Drug substance, Drug product 2015-08-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205266-001 8178563 2029-07-24 U-1722 Drug substance 2015-08-18 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N205266-001 8063043 2029-09-15 Drug substance, Drug product 2015-08-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205266-001 8178563 2029-02-06 U-1722 Drug substance 2015-08-18 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N205266-001 8063043 2029-09-15 Drug substance, Drug product 2015-08-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205266-001 8178563 2029-02-06 U-1722 Drug substance 2015-08-18 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N205266-001 8063043 2029-09-15 Drug substance, Drug product 2015-08-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205266-001 8178563 2029-02-06 U-1722 Drug substance 2015-08-18 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N205266-001 8063043 2029-09-15 Drug substance, Drug product 2015-08-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205266-001 8178563 2029-02-06 U-1722 Drug substance 2015-08-18 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N205266-001 8063043 2029-09-15 Drug substance, Drug product 2015-08-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205266-001 8178563 2029-07-24 U-1722 Drug substance 2015-08-18 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205266-001 8063043 2029-09-15 Drug substance, Drug product 2015-08-18 6a51e52b5d6a…
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 Odomzo SONIDEGIB Sun Pharmaceutical Industries, Inc. 028312dc-d155-4fd5-8abd-6bb9f011d3cc 2024-12-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 205266 application number: NDA205266 ndc (product): 47335-303
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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 47335-303 Odomzo sonidegib Sun Pharmaceutical Industries, Inc. NDA Current 47335-303 Odomzo sonidegib Sun Pharmaceutical Industries, Inc. NDA Current 47335-303 Odomzo sonidegib Sun Pharmaceutical Industries, Inc. NDA Current 47335-303 Odomzo sonidegib Sun Pharmaceutical Industries, Inc. NDA Current 47335-303 Odomzo sonidegib Sun Pharmaceutical Industries, Inc. NDA Current 47335-303 Odomzo sonidegib Sun Pharmaceutical Industries, Inc. NDA Current