Application 207141

Type: ANDA
Sponsor: PRAXAIR DISTRIBUTION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NOXIVENT	NITRIC OXIDE	GAS;INHALATION	100PPM	No	No
002	NOXIVENT	NITRIC OXIDE	GAS;INHALATION	800PPM	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207141-001	NOXIVENT	NITRIC OXIDE	100PPM	GAS / INHALATION			2018-10-02
A207141-002	NOXIVENT	NITRIC OXIDE	800PPM	GAS / INHALATION	AA		2018-10-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207141-002	AA

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 · 84 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
2026-08-18 06:07:40	2026-07	A207141-001	NOXIVENT	100PPM	GAS / INHALATION			2018-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207141-002	NOXIVENT	800PPM	GAS / INHALATION	AA		2018-10-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207141-001	NOXIVENT	100PPM	GAS / INHALATION			2018-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207141-002	NOXIVENT	800PPM	GAS / INHALATION	AA		2018-10-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207141-001	NOXIVENT	100PPM	GAS / INHALATION			2018-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207141-002	NOXIVENT	800PPM	GAS / INHALATION	AA		2018-10-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207141-001	NOXIVENT	100PPM	GAS / INHALATION			2018-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207141-002	NOXIVENT	800PPM	GAS / INHALATION	AA		2018-10-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207141-001	NOXIVENT	100PPM	GAS / INHALATION		RS	2018-10-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207141-002	NOXIVENT	800PPM	GAS / INHALATION	AA		2018-10-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207141-001	NOXIVENT	100PPM	GAS / INHALATION		RS	2018-10-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207141-002	NOXIVENT	800PPM	GAS / INHALATION	AA		2018-10-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207141-001	NOXIVENT	100PPM	GAS / INHALATION		RS	2018-10-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207141-002	NOXIVENT	800PPM	GAS / INHALATION	AA		2018-10-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207141-001	NOXIVENT	100PPM	GAS / INHALATION		RS	2018-10-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207141-002	NOXIVENT	800PPM	GAS / INHALATION	AA		2018-10-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207141-001	NOXIVENT	100PPM	GAS / INHALATION		RS	2018-10-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207141-002	NOXIVENT	800PPM	GAS / INHALATION	AA		2018-10-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207141-001	NOXIVENT	100PPM	GAS / INHALATION		RS	2018-10-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207141-002	NOXIVENT	800PPM	GAS / INHALATION	AA		2018-10-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207141-001	NOXIVENT	100PPM	GAS / INHALATION		RS	2018-10-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207141-002	NOXIVENT	800PPM	GAS / INHALATION	AA		2018-10-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207141-001	NOXIVENT	100PPM	GAS / INHALATION		RS	2018-10-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207141-002	NOXIVENT	800PPM	GAS / INHALATION	AA		2018-10-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207141-001	NOXIVENT	100PPM	GAS / INHALATION		RS	2018-10-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207141-002	NOXIVENT	800PPM	GAS / INHALATION	AA		2018-10-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207141-001	NOXIVENT	100PPM	GAS / INHALATION		RS	2018-10-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207141-002	NOXIVENT	800PPM	GAS / INHALATION	AA		2018-10-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207141-001	NOXIVENT	100PPM	GAS / INHALATION			2018-10-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207141-002	NOXIVENT	800PPM	GAS / INHALATION	AA		2018-10-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207141-001	NOXIVENT	100PPM	GAS / INHALATION			2018-10-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207141-002	NOXIVENT	800PPM	GAS / INHALATION	AA		2018-10-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207141-001	NOXIVENT	100PPM	GAS / INHALATION			2018-10-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207141-002	NOXIVENT	800PPM	GAS / INHALATION	AA		2018-10-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207141-001	NOXIVENT	100PPM	GAS / INHALATION			2018-10-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207141-002	NOXIVENT	800PPM	GAS / INHALATION	AA		2018-10-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207141-001	NOXIVENT	100PPM	GAS / INHALATION			2018-10-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207141-002	NOXIVENT	800PPM	GAS / INHALATION	AA		2018-10-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207141-001	NOXIVENT	100PPM	GAS / INHALATION			2018-10-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207141-002	NOXIVENT	800PPM	GAS / INHALATION	AA		2018-10-02	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207141-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207141-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207141-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207141-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207141-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207141-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207141-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207141-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207141-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207141-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207141-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207141-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207141-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207141-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207141-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207141-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207141-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207141-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207141-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207141-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207141-002	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207141-002	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207141-002	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207141-002	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207141-002	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207141-002	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207141-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207141-002	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207141-002	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207141-002	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207141-002	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207141-002	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207141-002	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207141-002	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207141-002	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207141-002	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207141-002	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207141-002	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207141-002	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207141-002	AA	1	`e64feba35796…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Noxivent	NITRIC OXIDE	VERO BIOTECH, INC.	4ff98b29-bcd3-82eb-e063-6394a90abf8c	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207141 application number: ANDA207141
Noxivent 102	NOXIVENT 102	Linde Gas & Equipment Inc	27586e4f-66f1-4583-981c-e0bccb8b02e0	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207141 application number: ANDA207141 ndc (product): 59579-102

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59579-101	Noxivent 101	Noxivent 101	Praxair Distribution, Inc	ANDA	Current
59579-101	Noxivent 101	Noxivent 101	Praxair Distribution, Inc	ANDA	Current
59579-101	Noxivent 101	Noxivent 101	Praxair Distribution, Inc	ANDA	Current
59579-101	Noxivent 101	Noxivent 101	Linde Gas & Equipment Inc	ANDA	Current
59579-102	Noxivent 102	Noxivent 102	Praxair Distribution, Inc	ANDA	Current
59579-102	Noxivent 102	Noxivent 102	Praxair Distribution, Inc	ANDA	Current
59579-102	Noxivent 102	Noxivent 102	Linde Gas & Equipment Inc	ANDA	Current
59579-102	Noxivent 102	Noxivent 102	Praxair Distribution, Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74648	ORIG	2023-06-29
55947	ORIG	2018-10-15