Application 201444

Type: NDA
Sponsor: HOPE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NITHIODOTE	SODIUM NITRITE; SODIUM THIOSULFATE	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	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
N201444-001	NITHIODOTE	SODIUM NITRITE; SODIUM THIOSULFATE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS		RLD, RS	2011-01-14

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N201444-001	11753301	2030-02-10	U-3681	Drug substance, Drug product	2023-09-12
N201444-001	12304813	2030-02-10		Drug product	2025-05-22
N201444-001	9687506	2030-02-10	U-3394	Drug product	2022-06-29
N201444-001	9687506	2030-02-10	U-3395	Drug product	2022-06-29
N201444-001	10479686	2030-07-07	U-3390	Drug product	2022-06-29
N201444-001	9345724	2030-07-07	U-2015	Drug substance, Drug product	2017-06-06
N201444-001	9585912	2030-07-07		Drug substance, Drug product	2017-06-06
N201444-001	8496973	2031-03-29	U-1419	Drug substance, Drug product	2013-08-02
N201444-001	8568793	2031-12-24		Drug substance, Drug product	2013-11-01

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	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 299 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	N201444-001	11753301	2030-02-10	U-3681	Drug substance, Drug product	2023-09-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201444-001	12304813	2030-02-10		Drug product	2025-05-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201444-001	9687506	2030-02-10	U-3394	Drug product	2022-06-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201444-001	9687506	2030-02-10	U-3395	Drug product	2022-06-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201444-001	10479686	2030-07-07	U-3390	Drug product	2022-06-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201444-001	9345724	2030-07-07	U-2015	Drug substance, Drug product	2017-06-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201444-001	9585912	2030-07-07		Drug substance, Drug product	2017-06-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201444-001	8496973	2031-03-29	U-1419	Drug substance, Drug product	2013-08-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201444-001	8568793	2031-12-24		Drug substance, Drug product	2013-11-01	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N201444-001	11753301	2030-02-10	U-3681	Drug substance, Drug product	2023-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201444-001	12304813	2030-02-10		Drug product	2025-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201444-001	9687506	2030-02-10	U-3394	Drug product	2022-06-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201444-001	9687506	2030-02-10	U-3395	Drug product	2022-06-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201444-001	10479686	2030-07-07	U-3390	Drug product	2022-06-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201444-001	9345724	2030-07-07	U-2015	Drug substance, Drug product	2017-06-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201444-001	9585912	2030-07-07		Drug substance, Drug product	2017-06-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201444-001	8496973	2031-03-29	U-1419	Drug substance, Drug product	2013-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201444-001	8568793	2031-12-24		Drug substance, Drug product	2013-11-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201444-001	11753301	2030-02-10	U-3681	Drug substance, Drug product	2023-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201444-001	12304813	2030-02-10		Drug product	2025-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201444-001	9687506	2030-02-10	U-3394	Drug product	2022-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201444-001	9687506	2030-02-10	U-3395	Drug product	2022-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201444-001	10479686	2030-07-07	U-3390	Drug product	2022-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201444-001	9345724	2030-07-07	U-2015	Drug substance, Drug product	2017-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201444-001	9585912	2030-07-07		Drug substance, Drug product	2017-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201444-001	8496973	2031-03-29	U-1419	Drug substance, Drug product	2013-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201444-001	8568793	2031-12-24		Drug substance, Drug product	2013-11-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201444-001	11753301	2030-02-10	U-3681	Drug substance, Drug product	2023-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201444-001	12304813	2030-02-10		Drug product	2025-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201444-001	9687506	2030-02-10	U-3394	Drug product	2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201444-001	9687506	2030-02-10	U-3395	Drug product	2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201444-001	10479686	2030-07-07	U-3390	Drug product	2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201444-001	9345724	2030-07-07	U-2015	Drug substance, Drug product	2017-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201444-001	9585912	2030-07-07		Drug substance, Drug product	2017-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201444-001	8496973	2031-03-29	U-1419	Drug substance, Drug product	2013-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201444-001	8568793	2031-12-24		Drug substance, Drug product	2013-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201444-001	11753301	2030-02-10	U-3681	Drug substance, Drug product	2023-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201444-001	12304813	2030-02-10		Drug product	2025-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201444-001	9687506	2030-02-10	U-3394	Drug product	2022-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201444-001	9687506	2030-02-10	U-3395	Drug product	2022-06-29	`31067a03dcf5…`

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
NITHIODOTE	SODIUM NITRITE AND SODIUM THIOSULFATE	Hope Pharmaceuticals	ff4941b3-9901-4aab-adcf-c5327bede34e	2025-10-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 201444 application number: NDA201444 ndc (product): 60267-812

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60267-812	NITHIODOTE	Sodium Nitrite and Sodium Thiosulfate	Hope Pharmaceuticals	NDA	Current
60267-812	NITHIODOTE	Sodium Nitrite and Sodium Thiosulfate	Hope Pharmaceuticals	NDA	Current
60267-812	NITHIODOTE	Sodium Nitrite and Sodium Thiosulfate	Hope Pharmaceuticals	NDA	Current
60267-812	NITHIODOTE	Sodium Nitrite and Sodium Thiosulfate	Hope Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65906	SUPPL	2021-01-14
65903	SUPPL	2021-01-14
50161	SUPPL	2017-10-24
50135	SUPPL	2017-10-23
43366	ORIG	2012-02-10
24393	ORIG	2012-02-10
19017	ORIG	2011-01-20
9895	ORIG	2011-01-20