Application 020468

Type: NDA
Sponsor: SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	NASACORT ALLERGY 24 HOUR	TRIAMCINOLONE ACETONIDE	SPRAY, METERED;NASAL	0.055MG/SPRAY	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
N020468-002	NASACORT ALLERGY 24 HOUR	TRIAMCINOLONE ACETONIDE	0.055MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2013-10-11

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	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020468-002	NASACORT ALLERGY 24 HOUR	0.055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2013-10-11	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nasacort Allergy 24HR	TRIAMCINOLONE ACETONIDE	Chattem, Inc.	4bff57a5-cce0-401c-a0fe-23c65c1b7ddc	2026-01-14	Warnings	Exact identifier application applno (NDA): 020468 application number: NDA020468 ndc (product): 41167-5800
NASACORT	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	37f290c9-576d-463f-b7d4-a146f53855b0	2025-04-23	Warnings	Exact identifier application applno (NDA): 020468 application number: NDA020468 ndc (product): 50090-1444

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
41167-5800	Nasacort Allergy 24HR	Triamcinolone Acetonide	Chattem, Inc.	NDA	Current
41167-5800	Nasacort Allergy 24HR	Triamcinolone Acetonide	Chattem, Inc.	NDA	Current
41167-5800	Nasacort Allergy 24HR	Triamcinolone Acetonide	Chattem, Inc.	NDA	Current
41167-5800	Nasacort Allergy 24HR	Triamcinolone Acetonide	Chattem, Inc.	NDA	Current
41167-5900	Childrens Nasacort Allergy 24HR	Triamcinolone Acetonide	Chattem, Inc.	NDA	Current
41167-5900	Childrens Nasacort Allergy 24HR	Triamcinolone Acetonide	Chattem, Inc.	NDA	Current
50090-1444	Nasacort Allergy 24HR	Triamcinolone Acetonide	A-S Medication Solutions	NDA	Current
50090-1444	Nasacort Allergy 24HR	Triamcinolone Acetonide	A-S Medication Solutions	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82194	SUPPL	2025-05-15
82190	SUPPL	2025-05-15
56100	SUPPL	2018-10-26
56055	SUPPL	2018-10-23
51868	SUPPL	2018-01-26
51430	SUPPL	2018-01-22
45531	SUPPL	2016-10-12
45603	SUPPL	2016-10-11
12613	SUPPL	2015-06-22
2571	SUPPL	2015-06-22
34680	SUPPL	2014-09-23
25003	SUPPL	2014-09-23
12612	SUPPL	2013-10-15
25002	SUPPL	2013-10-11
34679	SUPPL	2013-07-03
25001	SUPPL	2013-07-03
12611	SUPPL	2013-07-03
2570	SUPPL	2013-07-03
12610	SUPPL	2008-09-25
2569	SUPPL	2008-09-23
41379	SUPPL	2008-08-11
12609	SUPPL	2004-04-05
2568	SUPPL	2004-03-10
34678	SUPPL	2004-01-15
2567	SUPPL	2004-01-09
12608	SUPPL	2003-12-29
25000	SUPPL	2003-12-22
53430	SUPPL	1900-01-01
53429	SUPPL	1900-01-01
53428	SUPPL	1900-01-01