Application 208114

Type: NDA
Sponsor: JAZZ PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEFITELIO	DEFIBROTIDE SODIUM	SOLUTION;INTRAVENOUS	200MG/2.5ML (80MG/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N208114-001	DEFITELIO	DEFIBROTIDE SODIUM	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2016-03-30

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208114-001	11085043	2032-06-22		Drug product	2021-08-20
N208114-001	11236328	2032-06-22	U-3301		2022-02-17
N208114-001	11746348	2032-06-22		Drug product	2023-09-22
N208114-001	12529052	2032-06-22		Drug product	2026-02-17
N208114-001	12534722	2032-06-22		Drug product	2026-02-17

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208114-001	DEFITELIO	200MG/2.5ML (80MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-03-30	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 91 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208114-001	11085043	2032-06-22		Drug product	2021-08-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208114-001	11236328	2032-06-22	U-3301		2022-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208114-001	11746348	2032-06-22		Drug product	2023-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208114-001	12529052	2032-06-22		Drug product	2026-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208114-001	12534722	2032-06-22		Drug product	2026-02-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208114-001	11085043	2032-06-22		Drug product	2021-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208114-001	11236328	2032-06-22	U-3301		2022-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208114-001	11746348	2032-06-22		Drug product	2023-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208114-001	11085043	2032-06-22		Drug product	2021-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208114-001	11236328	2032-06-22	U-3301		2022-02-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208114-001	11746348	2032-06-22		Drug product	2023-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208114-001	11085043	2032-06-22		Drug product	2021-08-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208114-001	11236328	2032-06-22	U-3301		2022-02-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208114-001	11746348	2032-06-22		Drug product	2023-09-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208114-001	11085043	2032-06-22		Drug product	2021-08-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208114-001	11236328	2032-06-22	U-3301		2022-02-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208114-001	11746348	2032-06-22		Drug product	2023-09-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208114-001	11085043	2032-06-22		Drug product	2021-08-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208114-001	11236328	2032-06-22	U-3301		2022-02-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208114-001	11746348	2032-06-22		Drug product	2023-09-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208114-001	11085043	2032-06-22		Drug product	2021-08-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208114-001	11236328	2032-06-22	U-3301		2022-02-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208114-001	11746348	2032-06-22		Drug product	2023-09-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208114-001	11085043	2032-06-22		Drug product	2021-08-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208114-001	11236328	2032-06-22	U-3301		2022-02-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208114-001	11746348	2032-06-22		Drug product	2023-09-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208114-001	11085043	2032-06-22		Drug product	2021-08-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208114-001	11236328	2032-06-22	U-3301		2022-02-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208114-001	11746348	2032-06-22		Drug product	2023-09-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208114-001	11085043	2032-06-22		Drug product	2021-08-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208114-001	11236328	2032-06-22	U-3301		2022-02-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208114-001	11746348	2032-06-22		Drug product	2023-09-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208114-001	11085043	2032-06-22		Drug product	2021-08-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208114-001	11236328	2032-06-22	U-3301		2022-02-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208114-001	11746348	2032-06-22		Drug product	2023-09-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208114-001	11085043	2032-06-22		Drug product	2021-08-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208114-001	11236328	2032-06-22	U-3301		2022-02-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208114-001	11746348	2032-06-22		Drug product	2023-09-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208114-001	11085043	2032-06-22		Drug product	2021-08-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208114-001	11236328	2032-06-22	U-3301		2022-02-17	`301d65b070ca…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208114-001	ODE-112	2023-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208114-001	ODE-112	2023-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208114-001	ODE-112	2023-03-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208114-001	NCE	2021-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208114-001	ODE-112	2023-03-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208114-001	ODE-112	2023-03-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208114-001	NCE	2021-03-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208114-001	ODE-112	2023-03-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208114-001	NCE	2021-03-30	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208114-001	ODE-112	2023-03-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208114-001	NCE	2021-03-30	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208114-001	ODE-112	2023-03-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208114-001	NCE	2021-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208114-001	ODE-112	2023-03-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208114-001	NCE	2021-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208114-001	ODE-112	2023-03-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208114-001	NCE	2021-03-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208114-001	ODE-112	2023-03-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208114-001	NCE	2021-03-30	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208114-001	ODE-112	2023-03-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208114-001	NCE	2021-03-30	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208114-001	ODE-112	2023-03-30	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N208114-001	ODE-112	2023-03-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208114-001	ODE-112	2023-03-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208114-001	ODE-112	2023-03-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208114-001	ODE-112	2023-03-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208114-001	ODE-112	2023-03-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208114-001	ODE-112	2023-03-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208114-001	ODE-112	2023-03-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208114-001	ODE-112	2023-03-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208114-001	ODE-112	2023-03-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208114-001	ODE-112	2023-03-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208114-001	ODE-112	2023-03-30	`cb3db0bc1861…`

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
DEFITELIO	DEFIBROTIDE SODIUM	Jazz Pharmaceuticals, Inc.	2c3db989-d7ad-41ed-9ebf-698dcf6c24ec	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208114 application number: NDA208114 ndc (product): 68727-800

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68727-800	DEFITELIO	defibrotide sodium	Jazz Pharmaceuticals, Inc.	NDA	Current
68727-800	DEFITELIO	defibrotide sodium	Jazz Pharmaceuticals, Inc.	NDA	Current
68727-800	DEFITELIO	defibrotide sodium	Jazz Pharmaceuticals, Inc.	NDA	Current
68727-800	DEFITELIO	defibrotide sodium	Jazz Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43544	ORIG	2016-05-10
24533	ORIG	2016-05-10
32892	ORIG	2016-04-04
40617	ORIG	2016-03-30