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 1.

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2022-10-28 04:53 UTC	2022-10	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205266-001	8178563	2029-07-24	U-1722	Drug substance	2015-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205266-001	8063043	2029-09-15		Drug substance, Drug product	2015-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205266-001	10266523	2036-03-30		Drug substance, Drug product	2022-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205266-001	8178563	2029-07-24	U-1722	Drug substance	2015-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205266-001	8063043	2029-09-15		Drug substance, Drug product	2015-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205266-001	10266523	2036-03-30		Drug substance, Drug product	2022-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205266-001	8178563	2029-07-24	U-1722	Drug substance	2015-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205266-001	8063043	2029-09-15		Drug substance, Drug product	2015-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205266-001	10266523	2036-03-30		Drug substance, Drug product	2022-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205266-001	8178563	2029-07-24	U-1722	Drug substance	2015-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205266-001	8063043	2029-09-15		Drug substance, Drug product	2015-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205266-001	10266523	2036-03-30		Drug substance, Drug product	2022-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205266-001	8178563	2029-07-24	U-1722	Drug substance	2015-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205266-001	8063043	2029-09-15		Drug substance, Drug product	2015-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205266-001	10266523	2036-03-30		Drug substance, Drug product	2022-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205266-001	8178563	2029-07-24	U-1722	Drug substance	2015-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205266-001	8063043	2029-09-15		Drug substance, Drug product	2015-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205266-001	10266523	2036-03-30		Drug substance, Drug product	2022-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205266-001	8178563	2029-07-24	U-1722	Drug substance	2015-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205266-001	8063043	2029-09-15		Drug substance, Drug product	2015-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205266-001	10266523	2036-03-30		Drug substance, Drug product	2022-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205266-001	8178563	2029-07-24	U-1722	Drug substance	2015-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205266-001	8063043	2029-09-15		Drug substance, Drug product	2015-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205266-001	10266523	2036-03-30		Drug substance, Drug product	2022-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205266-001	8178563	2029-07-24	U-1722	Drug substance	2015-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205266-001	8063043	2029-09-15		Drug substance, Drug product	2015-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205266-001	10266523	2036-03-30		Drug substance, Drug product	2022-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205266-001	8178563	2029-07-24	U-1722	Drug substance	2015-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205266-001	8063043	2029-09-15		Drug substance, Drug product	2015-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205266-001	10266523	2036-03-30		Drug substance, Drug product	2022-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205266-001	8178563	2029-07-24	U-1722	Drug substance	2015-08-18	`79d66fd596c7…`
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…`

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	N205266-001	NCE	2020-07-24	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N205266-001	NCE	2020-07-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205266-001	NCE	2020-07-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205266-001	NCE	2020-07-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205266-001	NCE	2020-07-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205266-001	NCE	2020-07-24	`ea99ee380514…`

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

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75279	SUPPL	2023-08-24
75278	SUPPL	2023-08-24
75268	SUPPL	2023-08-23
59100	ORIG	2019-06-17
58728	SUPPL	2019-05-15
58667	SUPPL	2019-05-14
58666	SUPPL	2019-05-14
49845	SUPPL	2017-09-22
49776	SUPPL	2017-09-19
46655	SUPPL	2017-01-03
19631	SUPPL	2016-05-17
10434	SUPPL	2016-05-16
40458	SUPPL	2016-03-30
22981	ORIG	2015-08-28
40457	ORIG	2015-07-24
32650	ORIG	2015-07-24