Application 020845

Type: NDA
Sponsor: MALLINCKRODT HOSP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	INOMAX	NITRIC OXIDE	GAS;INHALATION	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	INOMAX	NITRIC OXIDE	GAS;INHALATION	800PPM	Yes	Yes
004	INOMAX	NITRIC OXIDE	GAS;INHALATION	4880PPM	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020845-002	INOMAX	NITRIC OXIDE	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23
N020845-003	INOMAX	NITRIC OXIDE	800PPM	GAS / INHALATION	AA	RLD, RS	1999-12-23
N020845-004	INOMAX	NITRIC OXIDE	4880PPM	GAS / INHALATION		RLD, RS	2023-01-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N020845-003	AA

Orange Book patents#

Current patent rows page 1 of 1 · 53 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N020845-002	8282966	2029-06-30	U-1286		2012-10-10
N020845-002	8293284	2029-06-30	U-1286
N020845-002	8431163	2029-06-30	U-1286		2013-05-01
N020845-002	8795741	2029-06-30	U-1286		2014-08-07
N020845-002	8846112	2029-06-30	U-1286		2014-10-02
N020845-002	8282966*PED	2029-12-30		Pediatric extension
N020845-002	8293284*PED	2029-12-30		Pediatric extension
N020845-002	8431163*PED	2029-12-30		Pediatric extension
N020845-002	8795741*PED	2029-12-30		Pediatric extension
N020845-002	8846112*PED	2029-12-30		Pediatric extension
N020845-002	8291904	2031-01-06	U-1226	Drug product
N020845-002	8573209	2031-01-06		Drug product	2013-12-04
N020845-002	8573210	2031-01-06	U-1453	Drug product	2013-12-04
N020845-002	8776794	2031-01-06	U-1226	Drug product	2014-07-23
N020845-002	8776795	2031-01-06	U-1226	Drug product	2014-07-23
N020845-002	8291904*PED	2031-07-06		Pediatric extension
N020845-002	8573209*PED	2031-07-06		Pediatric extension
N020845-002	8573210*PED	2031-07-06		Pediatric extension
N020845-002	8776794*PED	2031-07-06		Pediatric extension
N020845-002	8776795*PED	2031-07-06		Pediatric extension
N020845-003	11931377	2029-06-30	U-3903	Drug substance, Drug product	2024-05-06
N020845-003	8282966	2029-06-30	U-1286
N020845-003	8293284	2029-06-30	U-1286
N020845-003	8431163	2029-06-30	U-1286
N020845-003	8795741	2029-06-30	U-1286		2014-08-07
N020845-003	8846112	2029-06-30	U-1286		2014-10-02
N020845-003	11931377*PED	2029-12-30		Pediatric extension
N020845-003	8282966*PED	2029-12-30		Pediatric extension
N020845-003	8293284*PED	2029-12-30		Pediatric extension
N020845-003	8431163*PED	2029-12-30		Pediatric extension
N020845-003	8795741*PED	2029-12-30		Pediatric extension
N020845-003	8846112*PED	2029-12-30		Pediatric extension
N020845-003	8291904	2031-01-06	U-1226	Drug product
N020845-003	8573209	2031-01-06		Drug product	2013-12-04
N020845-003	8573210	2031-01-06	U-1453	Drug product	2013-12-04
N020845-003	8776794	2031-01-06	U-1226	Drug product	2014-07-23
N020845-003	8776795	2031-01-06	U-1226	Drug product	2014-07-23
N020845-003	9265911	2031-01-06	U-1824	Drug product	2016-03-18
N020845-003	9295802	2031-01-06	U-1226	Drug product	2016-04-06
N020845-003	9408993	2031-01-06	U-1824	Drug product	2016-08-17
N020845-003	8291904*PED	2031-07-06		Pediatric extension
N020845-003	8573209*PED	2031-07-06		Pediatric extension
N020845-003	8573210*PED	2031-07-06		Pediatric extension
N020845-003	8776794*PED	2031-07-06		Pediatric extension
N020845-003	8776795*PED	2031-07-06		Pediatric extension
N020845-003	9265911*PED	2031-07-06		Pediatric extension
N020845-003	9295802*PED	2031-07-06		Pediatric extension
N020845-003	9408993*PED	2031-07-06		Pediatric extension
N020845-003	9279794	2035-02-19	U-1823	Drug product	2016-03-18
N020845-003	9279794*PED	2035-08-19		Pediatric extension
N020845-003	9770570	2036-05-03	U-2148		2017-10-25
N020845-003	9770570*PED	2036-11-03		Pediatric extension
N020845-004	11931377	2029-06-30	U-3903	Drug substance, Drug product	2024-05-06

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 3 · 96 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
2026-02-19 14:30 UTC	2026-02	N020845-002	INOMAX	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	INOMAX	800PPM	GAS / INHALATION	AA	RLD, RS	1999-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-004	INOMAX	4880PPM	GAS / INHALATION		RLD, RS	2023-01-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020845-002	INOMAX	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020845-003	INOMAX	800PPM	GAS / INHALATION	AA	RLD, RS	1999-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020845-004	INOMAX	4880PPM	GAS / INHALATION		RLD, RS	2023-01-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020845-002	INOMAX	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020845-003	INOMAX	800PPM	GAS / INHALATION	AA	RLD, RS	1999-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020845-004	INOMAX	4880PPM	GAS / INHALATION		RLD, RS	2023-01-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020845-002	INOMAX	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020845-003	INOMAX	800PPM	GAS / INHALATION	AA	RLD, RS	1999-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020845-004	INOMAX	4880PPM	GAS / INHALATION		RLD, RS	2023-01-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020845-002	INOMAX	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020845-003	INOMAX	800PPM	GAS / INHALATION	AA	RLD, RS	1999-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020845-004	INOMAX	4880PPM	GAS / INHALATION		RLD, RS	2023-01-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020845-002	INOMAX	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020845-003	INOMAX	800PPM	GAS / INHALATION	AA	RLD, RS	1999-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020845-004	INOMAX	4880PPM	GAS / INHALATION		RLD, RS	2023-01-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020845-002	INOMAX	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020845-003	INOMAX	800PPM	GAS / INHALATION	AA	RLD, RS	1999-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020845-004	INOMAX	4880PPM	GAS / INHALATION		RLD, RS	2023-01-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020845-002	INOMAX	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020845-003	INOMAX	800PPM	GAS / INHALATION	AA	RLD, RS	1999-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020845-004	INOMAX	4880PPM	GAS / INHALATION		RLD, RS	2023-01-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020845-002	INOMAX	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020845-003	INOMAX	800PPM	GAS / INHALATION	AA	RLD, RS	1999-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020845-004	INOMAX	4880PPM	GAS / INHALATION		RLD, RS	2023-01-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020845-002	INOMAX	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020845-003	INOMAX	800PPM	GAS / INHALATION	AA	RLD, RS	1999-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020845-004	INOMAX	4880PPM	GAS / INHALATION		RLD, RS	2023-01-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020845-002	INOMAX	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020845-003	INOMAX	800PPM	GAS / INHALATION	AA	RLD, RS	1999-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020845-004	INOMAX	4880PPM	GAS / INHALATION		RLD, RS	2023-01-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020845-002	INOMAX	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020845-003	INOMAX	800PPM	GAS / INHALATION	AA	RLD, RS	1999-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020845-004	INOMAX	4880PPM	GAS / INHALATION		RLD, RS	2023-01-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020845-002	INOMAX	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020845-003	INOMAX	800PPM	GAS / INHALATION	AA	RLD, RS	1999-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020845-004	INOMAX	4880PPM	GAS / INHALATION		RLD, RS	2023-01-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020845-002	INOMAX	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020845-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020845-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020845-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020845-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020845-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020845-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020845-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020845-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020845-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020845-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020845-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020845-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020845-003	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020845-003	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020845-003	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020845-003	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020845-003	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020845-003	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020845-003	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020845-003	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020845-003	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020845-003	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020845-003	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020845-003	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020845-003	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020845-003	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020845-003	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020845-003	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020845-003	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020845-003	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020845-003	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020845-003	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020845-003	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020845-003	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020845-003	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020845-003	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020845-003	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020845-003	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020845-003	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020845-003	AA	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 53 · 2,092 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	N020845-002	8282966	2029-06-30	U-1286		2012-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8293284	2029-06-30	U-1286			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8431163	2029-06-30	U-1286		2013-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8795741	2029-06-30	U-1286		2014-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8846112	2029-06-30	U-1286		2014-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8282966*PED	2029-12-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8293284*PED	2029-12-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8431163*PED	2029-12-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8795741*PED	2029-12-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8846112*PED	2029-12-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8291904	2031-01-06	U-1226	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8573209	2031-01-06		Drug product	2013-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8573210	2031-01-06	U-1453	Drug product	2013-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8776794	2031-01-06	U-1226	Drug product	2014-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8776795	2031-01-06	U-1226	Drug product	2014-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8291904*PED	2031-07-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8573209*PED	2031-07-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8573210*PED	2031-07-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8776794*PED	2031-07-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8776795*PED	2031-07-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	11931377	2029-06-30	U-3903	Drug substance, Drug product	2024-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8282966	2029-06-30	U-1286			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8293284	2029-06-30	U-1286			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8431163	2029-06-30	U-1286			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8795741	2029-06-30	U-1286		2014-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8846112	2029-06-30	U-1286		2014-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	11931377*PED	2029-12-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8282966*PED	2029-12-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8293284*PED	2029-12-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8431163*PED	2029-12-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8795741*PED	2029-12-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8846112*PED	2029-12-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8291904	2031-01-06	U-1226	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8573209	2031-01-06		Drug product	2013-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8573210	2031-01-06	U-1453	Drug product	2013-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8776794	2031-01-06	U-1226	Drug product	2014-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8776795	2031-01-06	U-1226	Drug product	2014-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	9265911	2031-01-06	U-1824	Drug product	2016-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	9295802	2031-01-06	U-1226	Drug product	2016-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	9408993	2031-01-06	U-1824	Drug product	2016-08-17	`011fe1cb6892…`

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
INOMAX	NITRIC OXIDE	INO Therapeutics LLC	762b51be-1893-4cd1-9511-e645fc420d3a	2025-12-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020845 application number: NDA020845 ndc (product): 64693-002

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64693-002	INOmax	nitric oxide	INO THERAPEUTICS LLC	NDA	Current
64693-002	INOmax	nitric oxide	INO Therapeutics	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73788	SUPPL	2023-03-17
73787	SUPPL	2023-03-17
57608	SUPPL	2019-02-14
57592	SUPPL	2019-02-14
21018	SUPPL	2016-07-27
21017	SUPPL	2016-07-27
3570	SUPPL	2016-04-07
35505	SUPPL	2015-10-15
13610	SUPPL	2015-10-15
26047	SUPPL	2015-10-14
26046	SUPPL	2015-10-14
13609	SUPPL	2013-03-08
3569	SUPPL	2013-03-05
13608	SUPPL	2010-12-22
3568	SUPPL	2010-12-22
3567	SUPPL	2009-11-19
13607	SUPPL	2009-09-17
26045	SUPPL	2008-01-09
3566	SUPPL	2004-06-16
26044	ORIG	1999-12-23
21016	ORIG	1999-12-23
13606	ORIG	1999-12-23
64026	ORIG	1900-01-01
53352	ORIG	1900-01-01
53351	ORIG	1900-01-01
53350	ORIG	1900-01-01